<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03826667</url>
  </required_header>
  <id_info>
    <org_study_id>2018.16.SMD.PEEK.RET.SHD</org_study_id>
    <nct_id>NCT03826667</nct_id>
  </id_info>
  <brief_title>PMCF Study on PEEK Suture Anchors for Shoulder Indications</brief_title>
  <official_title>Post-market Clinical Follow-up (PMCF) Study on PEEK Suture Anchors for Shoulder Indications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Smith &amp; Nephew, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Smith &amp; Nephew, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Actual">August 28, 2019</completion_date>
  <primary_completion_date type="Actual">August 28, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered &quot;Yes&quot; based on the following 3 main criteria:&#xD;
no inflammatory or allergic response&#xD;
no device-related adverse event (AE)&#xD;
no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered &quot;Yes&quot; based on the following 3 main criteria:&#xD;
no inflammatory or allergic response&#xD;
no device-related adverse event (AE)&#xD;
no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS) - Pain</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Count of Participants With Range of Motion (ROM) Full Functional Arc</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Range of motion defined as the participant having a full functional arc &quot;Yes&quot; or &quot;No&quot; at 6 month and 12 month post-operative visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion (ROM)</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.</description>
  </secondary_outcome>
  <enrollment type="Actual">464</enrollment>
  <condition>Soft Tissue to Bone Fixation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Polyetheretherketone (PEEK) Shoulder Suture Anchors</intervention_name>
    <description>PEEK Suture Anchors, which include:&#xD;
HEALICOIL™ PK Preloaded Suture Anchors&#xD;
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors&#xD;
BIORAPTOR™ Knotless Suture Anchors&#xD;
MULTIFIX™ S Ultra Knotless Fixation System&#xD;
FOOTPRINT™ Ultra PK Suture Anchors&#xD;
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles&#xD;
SPEEDSCREW™ Knotless Fixation System&#xD;
SpeedLock Knotless Fixation Device</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who have received PEEK Suture Anchors implanted in the shoulder&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who have undergone shoulder joint repair using the study devices.&#xD;
&#xD;
          2. Subjects aged 18 years and older at the time of surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who are &lt; 12 months post-operative.&#xD;
&#xD;
          2. Subject is entered in another investigational drug, biologic, or device study or has&#xD;
             been treated with an investigational product within 30 days prior to surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Judth Horner</last_name>
    <role>Study Chair</role>
    <affiliation>Smith &amp; Nephew, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grandview Medical Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoArizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado- Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital/Orthopedic Institute</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoAtlanta</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Hospital</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Orthopedics Center</name>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist at Baytown</name>
      <address>
        <city>Baytown</city>
        <state>Texas</state>
        <zip>77521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Orthopedic Hospital - Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspen Orthopedics at New Berlin</name>
      <address>
        <city>New Berlin</city>
        <state>Wisconsin</state>
        <zip>53151</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspen Orthopedics at West Allis</name>
      <address>
        <city>West Allis</city>
        <state>Wisconsin</state>
        <zip>80222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <results_first_submitted>October 22, 2021</results_first_submitted>
  <results_first_submitted_qc>February 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 12, 2022</results_first_posted>
  <last_update_submitted>February 12, 2022</last_update_submitted>
  <last_update_submitted_qc>February 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03826667/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>It was intended to enroll participants for 8 PEEK suture anchor devices; however, no participants were enrolled for the BIORAPTOR™ Knotless Suture Anchors, resulting in 7 suture anchor groups being analyzed. A total of 464 participants were enrolled in the study and 467 joints were observed. Multiple devices were implanted in 124 participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Polyetheretherketone (PEEK) Shoulder Suture Anchors</title>
          <description>Participants who have received PEEK Suture Anchors in the shoulder which included:&#xD;
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="464"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>HEALICOIL™ PK Preloaded Suture Anchors</title>
              <participants_list>
                <participants group_id="P1" count="193"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>MULTIFIX™ S Ultra Knotless Fixation System</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>FOOTPRINT™ Ultra PK Suture Anchors</title>
              <participants_list>
                <participants group_id="P1" count="136"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>SPEEDSCREW™ Knotless Fixation System</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>SpeedLock Knotless Fixation Device</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="443"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants enrolled in the study who had previously undergone shoulder repair using PEEK suture anchors (i.e., retrospective data). The type(s) of PEEK anchor used during surgery was surgeon decision on a case by case basis. Multiple anchor types could be used in one surgery if required. 124 participants had multiple devices implanted. Participants with bilateral surgeries had both surgeries recorded independently. Device data analyzed individually dependent on unique suture anchor implanted.</population>
      <group_list>
        <group group_id="B1">
          <title>Polyetheretherketone (PEEK) Shoulder Suture Anchors</title>
          <description>Participants who have received PEEK Suture Anchors in the shoulder which included:&#xD;
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="464"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>joints</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="467"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>joints</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="464"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>joints</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.00" spread="14.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>joints</units>
          <param>Count of Units</param>
          <units_analyzed>joints</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="464"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>joints</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="190"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>joints</units>
          <param>Count of Units</param>
          <units_analyzed>joints</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="464"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>joints</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="367"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>joints</units>
          <param>Count of Units</param>
          <units_analyzed>joints</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="464"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>joints</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="462"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="464"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="444"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="465"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="373"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="403"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>joints</units>
          <param>Number</param>
          <units_analyzed>joints</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="464"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>joints</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="467"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Location of Device Implantation</title>
          <units>joints</units>
          <param>Count of Units</param>
          <units_analyzed>joints</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="464"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>joints</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Left Shoulder</title>
                  <measurement_list>
                    <measurement group_id="B1" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Right Shoulder</title>
                  <measurement_list>
                    <measurement group_id="B1" value="271"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bilaterally</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Surgery</title>
          <population>Data was not available for all participants due to the retrospective nature of the study.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="113"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>joints</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="99.2" spread="50.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of time from injury to surgery</title>
          <population>Data not available for all participants due to the retrospective nature of the study.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="235"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>joints</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="405.7" spread="929.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Any Medical History</title>
          <units>joints</units>
          <param>Count of Units</param>
          <units_analyzed>joints</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="464"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>joints</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="392"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participant Joints Treated by Indication</title>
          <units>joints</units>
          <param>Count of Units</param>
          <units_analyzed>joints</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="464"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>joints</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Bankart lesion repair</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SLAP lesion repair</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Capsular shift</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rotator cuff repair</title>
                  <measurement_list>
                    <measurement group_id="B1" value="413"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Biceps tenodesis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disposition of Suture Anchors</title>
          <description>Count of participants by unique PEEK Suture Anchors implanted.</description>
          <population>Information provided based on the unique device implanted. Out of 464 overall participants, 124 were implanted with multiple Suture Anchors (devices).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="464"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>joints</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention</title>
        <description>Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered &quot;Yes&quot; based on the following 3 main criteria:&#xD;
no inflammatory or allergic response&#xD;
no device-related adverse event (AE)&#xD;
no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder</description>
        <time_frame>6 months</time_frame>
        <population>Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.</population>
        <group_list>
          <group group_id="O1">
            <title>Polyetheretherketone (PEEK) Shoulder Suture Anchors</title>
            <description>Participants who have received PEEK Suture Anchors in the shoulder which included:&#xD;
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention</title>
          <description>Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered &quot;Yes&quot; based on the following 3 main criteria:&#xD;
no inflammatory or allergic response&#xD;
no device-related adverse event (AE)&#xD;
no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder</description>
          <population>Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="458"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention</title>
        <description>Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered &quot;Yes&quot; based on the following 3 main criteria:&#xD;
no inflammatory or allergic response&#xD;
no device-related adverse event (AE)&#xD;
no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder</description>
        <time_frame>12 months</time_frame>
        <population>Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.</population>
        <group_list>
          <group group_id="O1">
            <title>Polyetheretherketone (PEEK) Shoulder Suture Anchors</title>
            <description>Participants who have received PEEK Suture Anchors in the shoulder which included:&#xD;
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention</title>
          <description>Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered &quot;Yes&quot; based on the following 3 main criteria:&#xD;
no inflammatory or allergic response&#xD;
no device-related adverse event (AE)&#xD;
no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder</description>
          <population>Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Scale (VAS) - Pain</title>
        <description>The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.</description>
        <time_frame>6 and 12 months</time_frame>
        <population>Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.</population>
        <group_list>
          <group group_id="O1">
            <title>Polyetheretherketone (PEEK) Shoulder Suture Anchors</title>
            <description>Participants who have received PEEK Suture Anchors in the shoulder which included:&#xD;
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS) - Pain</title>
          <description>The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.</description>
          <population>Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Count of Participants With Range of Motion (ROM) Full Functional Arc</title>
        <description>Range of motion defined as the participant having a full functional arc &quot;Yes&quot; or &quot;No&quot; at 6 month and 12 month post-operative visits.</description>
        <time_frame>6 and 12 months</time_frame>
        <population>Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.</population>
        <group_list>
          <group group_id="O1">
            <title>Polyetheretherketone (PEEK) Shoulder Suture Anchors</title>
            <description>Participants who have received PEEK Suture Anchors in the shoulder which included:&#xD;
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With Range of Motion (ROM) Full Functional Arc</title>
          <description>Range of motion defined as the participant having a full functional arc &quot;Yes&quot; or &quot;No&quot; at 6 month and 12 month post-operative visits.</description>
          <population>Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="348"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                </category>
              </category_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                </category>
              </category_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device: 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device: 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Has full functional arc: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Has full functional arc: Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Range of Motion (ROM)</title>
        <description>Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.</description>
        <time_frame>6 and 12 months</time_frame>
        <population>Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.</population>
        <group_list>
          <group group_id="O1">
            <title>Polyetheretherketone (PEEK) Shoulder Suture Anchors</title>
            <description>Participants who have received PEEK Suture Anchors in the shoulder which included:&#xD;
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device</description>
          </group>
        </group_list>
        <measure>
          <title>Range of Motion (ROM)</title>
          <description>Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.</description>
          <population>Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors: Forward Flexion Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157" spread="20.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors: Internal Rotation Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.7" spread="40.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors: External Rotation (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.3" spread="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors Forward Flexion Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.1" spread="39.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors Internal Rotation Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" spread="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEALICOIL™ PK Preloaded Suture Anchors External Rotation (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.4" spread="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Forward Flexion Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" spread="100.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Internal Rotation Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: External Rotation (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" spread="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Forward Flexion Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Internal Rotation Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: External Rotation (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System: Forward Flexion Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122.5" spread="39.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System: Internal Rotation Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" spread="NA">Standard deviation not calculated whenever there was only 1 participant's data available</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System: External Rotation (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.8" spread="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System: Forward Flexion Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.7" spread="38.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System: Internal Rotation Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" spread="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIFIX™ S Ultra Knotless Fixation System: External Rotation (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor: Forward Flexion Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137.5" spread="35.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor: Internal Rotation Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.3" spread="30.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor: External Rotation (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" spread="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor: Forward Flexion Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140" spread="28.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor: Internal Rotation Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>FOOTPRINT™ Ultra PK Suture Anchor: External Rotation (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor: Forward Flexion Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor: Internal Rotation Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor: External Rotation (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor: Forward Flexion Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor: Internal Rotation Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>TWINFIX™ Ultra PK Suture Anchor: External Rotation (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System: Forward Flexion Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122" spread="46.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System: Internal Rotation Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System: External Rotation (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System: Forward Flexion Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130" spread="NA">Standard deviation not calculated whenever there was only 1 participant's data available</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System: Internal Rotation Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>SPEEDSCREW™ Knotless Fixation System: External Rotation (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" spread="NA">Standard deviation not calculated whenever there was only 1 participant's data available</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device: Forward Flexion Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device: Internal Rotation Angle (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device: External Rotation (6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device: Forward Flexion Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device: Internal Rotation Angle (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>SpeedLock Knotless Fixation Device: External Rotation (12 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Surgery to End of Study (EOS) visit, approximately 12 months</time_frame>
      <desc>AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).</desc>
      <group_list>
        <group group_id="E1">
          <title>HEALICOIL™ PK Preloaded Suture Anchors</title>
          <description>Participants who have received PEEK Suture Anchor:&#xD;
HEALICOIL™ PK Preloaded Suture Anchors</description>
        </group>
        <group group_id="E2">
          <title>BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors</title>
          <description>Participants who have received PEEK Suture Anchor:&#xD;
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors</description>
        </group>
        <group group_id="E3">
          <title>MULTIFIX™ S Ultra Knotless Fixation System</title>
          <description>Participants who have received PEEK Suture Anchor:&#xD;
MULTIFIX™ S Ultra Knotless Fixation System</description>
        </group>
        <group group_id="E4">
          <title>FOOTPRINT™ Ultra PK Suture Anchors</title>
          <description>Participants who have received PEEK Suture Anchor:&#xD;
FOOTPRINT™ Ultra PK Suture Anchors</description>
        </group>
        <group group_id="E5">
          <title>TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles</title>
          <description>Participants who have received PEEK Suture Anchor:&#xD;
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles</description>
        </group>
        <group group_id="E6">
          <title>SPEEDSCREW™ Knotless Fixation System</title>
          <description>Participants who have received PEEK Suture Anchor:&#xD;
SPEEDSCREW™ Knotless Fixation System</description>
        </group>
        <group group_id="E7">
          <title>SpeedLock Knotless Fixation Device</title>
          <description>Participants who have received PEEK Suture Anchor:&#xD;
SpeedLock Knotless Fixation Device</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="78"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="136"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="59"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>PULMONARY EMBOLUS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>SPLENIC NECROSIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>LEFT SHOULDER PAIN WITH RECURRENT RTC TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER INCREASE IN PAIN WITH POPPING AND GRINDING, RECURRENT RTC TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>R SHOULDER INCREASED PAIN, WEAKNESS, LTD. ROM, R RECURRENT RTC TEAR</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>FELT POP R SHOULDER, DECREASED ROM AND PAIN SINCE, RECURRENT RTC TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER SWELLING AND PAIN AFTER PT STRETCH AND RECURRENT LEFT RTC TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>R SHOULDER PAIN CREPITUS AND STIFFNESS WITH RECURRENT RTC TEAR,</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER PAIN AND WEAKNESS, RECURRENT R RTC TEAR,</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INCREASED PAIN, DECREASED ROM AND WEAKNESS, RECURRENT L RTC TEAR, INSOMNIA R/T PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>WORSENING LEFT SHOULDER PAIN RADIATING DOWN LEFT ARM, RECURRENT LABRAL TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER PAIN WITH DECREASED ROM, STIFF AND SORE, ADHESIVE CAPSULITIS AND RTC TENDONITIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER PAIN, LTD ROM, RTC TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>R SHOULDER PAIN, RECURRENT RTC TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>R SHOULDER ANTERIOR WOUND INFECTION</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>RE-TEAR OF ROTATOR CUFF</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER RECURRENT ROTATOR CUFF TEAR</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>R RECURRENT RTC TEAR AND IMPINGEMENT SYNDROME</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RECURRENT TEAR OF ROTATOR CUFF WITH NEW TEAR OF THE SUPRASPINATUS AND RECURRENT JOINT IMPINGEMENT</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT RTC TEAR, RTC CAPSULE SPRAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>R SHOULDER TENDONITIS, PARTIAL RTC TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>R RTC TEAR, TENDONITIS AND WEAKNESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CLAVICLE FRACTURE AFTER FALL AT WORK</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ADHESIVE CAPSULITIS IN RIGHT SHOULDER</sub_title>
                <description>Unlikely related to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER ADHESIVE CAPSULITIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DECREASED ROM RIGHT SHOULDER</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CONTINUING WEAKNESS RIGHT SHOULDER AND DECREASED ROM</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER PAIN AND DECREASED ROM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RECURRENT RTC TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER ADHESIVE CAPSULITIS</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>R SHOULDER SUBACHROMIAL BURSITIS WITH SUPRASPINATOUS TENDINOSIS CAUSING DECREASED MOBILITY</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER PAIN, TIGHTNESS AND SPASM WITH PERSISTENT WEAKNESS AND RECURRENT RTC TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>RIGHT CARPAL TUNNEL WITH RELEASE</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>PNEMOTHORAX- RIGHT</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>OCCASIONAL LEFT SHOULDER PAIN, STIFFNESS, ADHESIVE CAPSULITIS</sub_title>
                <description>Probable to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="38" subjects_at_risk="78"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="136"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="57"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="59"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERLIPIDEMIA</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>NEW ONSET ATRIAL FIBRILLATION</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>RECURRENT 6MM RIGHT RTC TEAR SECONDARY TO DIABETES AND SMOKING CAUSING POOR TISSUE QUALITY</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>NAUSEA AND CONSTIPATION R/T POST-OP OXYCONTIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DIVERTICULITIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN AND CONSTIPATION</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>NAUSEA FROM PAIN MEDICATION</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>WORSENING LEFT SHOULDER PAIN AND DECREASED ROM</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>COMPLEX REGIONAL PAIN SYNDROME TYPE II</sub_title>
                <description>Unlikely related to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PAIN ON THE RIGHT SIDE OF HER SHOULDER DOWN HER NECK AND THE MEDIAL BORDER OF HER RIGHT SCAPULA.</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SIDE ARM PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>SHOULDER PAIN POST FALL</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT HAND NUMBNESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CONTINUED LEFT SHOULDER WEAKNESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ACTIVE RANGE OF MOTION LIMITED BY PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>SHOOTING PAIN DOWN LEFT ARM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT HAND CONTUSION</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INCREASE IN RIGHT SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT ARM LIMITED ROM SECONDARY RIGHT SHOULDER PAIN FROM LIFTING INJURY</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>BILATERAL SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER INCREASING PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER CLICKING, NUMBNESS LEFT ARM, LEFT 4TH AND 5TH FINGERS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INSOMNIA R/T LEFT SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER PAIN WITH EXERCISING</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER STIFFNESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER SORENESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>NUMBNESS RIGHT THUMB</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HERNIATED DISC WITH MYELOPATHY, CONTINUED RIGHT ARM WEAKNESS, RIGHT SCAPULA AREA AND SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>WORSENING RIGHT SHOULDER PAIN AND SWELLING</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER SORENESS AT TIMES</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INSOMNIA SECONDARY TO RIGHT SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>POSTERIOR/LATERAL NUMBNESS RIGHT ARM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER SWELLING</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PAINFUL ROM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INCREASING RIGHT SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CONTINUING SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PAIN DOWN ARM TO LEFT HAND 4TH AND 5TH FINGERS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER BURSITIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER PAIN WITH DECREASED ROM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER PAIN AFTER PT STRENGTHENING EXERCISES</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>TINGLING FROM LEFT ELBOW TO WRIST</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT ELBOW WARM TO TOUCH WITH DECREASED MOBILITY AND PAIN RADIATING TO WRIST</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="193"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER LIMITED ROM AND WEAKNESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INCREASED PAIN RIGHT ANKLE</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>WORSENING PAIN RIGHT SHOULDER</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER PAIN, STIFFNESS, NUMBNESS AND DECREASED SENSATION RELATED TO RECURRENT RTC TEAR</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER ACHING PAIN WITH CERTAIN MOVEMENTS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER MILD PAIN AND WEAKNESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DECREASED LEFT SHOULDER STRENGTH</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER DECREASED ROM AND STRENGTH RELATED RTC RUPTURE</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER PAIN WITH DECREASED ROM</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER CONSTANT PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT ARM PAIN BICEP REGION AND LEFT SHOULDER SWELLING</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>OCCASIONAL SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="193"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER PAIN AND WEAKNESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER DULL PAIN AFTER STRENUOUS ACTIVITY</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INTERMITTENT LEFT SHOULDER PAIN SINCE EXERCISING</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INTERMITTENT EPISODES OF PERSPIRING AND FEELING OF EXHAUSTION</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER DECREASED ROM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER WEAKNESS AND PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INTERMITTENT LEFT BICEP PAIN AND CRAMPING</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INCREASED LUE PAIN WITH NUMBNESS AND TINGLING TO LEFT RADIAL DIGITS AND INSOMNIA RELATED TO PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INCREASING LEFT SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>THUMB PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER PAIN AND RESIDUAL WEAKNESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER PAIN, LTD. ROM, WEAKNESS, DISUSE ATROPHY</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER STIFFNESS, CONSTANT SORENESS, DECREASED ROM, ACHING AND WEAKNESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT ANTERIOR SHIN NEURALGIA/SPRAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>MIGRAINE HEADACHES</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>OCCASIONAL DEEP LEFT SHOULDER PAIN</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT ARM WEAKNESS</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>L SHOULDER PAIN W/LTD. ROM AND STRENGTH</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INCREASED LEFT SHOULDER PAIN, HYPERSENSITIVITY AND PARASTHESIA, QUESTION POSSIBLE RSD</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INTERMITTENT LEFT SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER PAIN WITH DECREASED ROM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER PAIN WITH TIGHTNESS, WEAKNESS, AND DECREASED ROM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INTERMITTENT RIGHT SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER STIFFNESS AND LTD. ROM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER SWELLING AND PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER STIFFNESS &quot;SLEPT ON IT WRONG&quot;</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>OCCASIONAL LEFT SHOULDER DECREASED ROM, PAIN, AND WEAKNESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RETURNING LEFT SHOULDER PAIN</sub_title>
                <description>Unlikely related to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>R SHOULDER PAIN, DECREASED ROM AND BICEPS AREA PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER INTERMITTENT PAIN AND DECREASED ROM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CONTINUING RIGHT SHOULDER PAIN AND DECREASED ROM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>REACHING IN PT AND FELT A &quot;POP&quot; WITH INCREASED PAIN RIGHT SHOULDER</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>WORSENING PAIN RIGHT SHOULDER</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER CONTINUING PAIN</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER PAIN AT NIGHT</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER POST. INCISION OPEN W/BLOOD DRAINAGE- SUTURE FELL OUT</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER WORSENING PAIN, LTD ROM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RECURRING RIGHT ELBOW PAIN, ACUTE RIGHT EPICONDYLITIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>L SHOULDER PAIN, DECREASED ROM W/DIFFICULTY SLEEPING @ NIGHT, POSSIBLE ADHESIVE CAPSULITIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT ELBOW PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT FOREARM PAIN AND MUSCLE SPASMS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER INSTABILITY AND PAIN R/T STRAIN/SPRAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RECURRENT RIGHT SHOULDER PAIN, POST-OP REVISION</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>LEFT HAND THIRD FINGER PARONYCHIA VERY PAINFUL AND TENDER</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER SWELLING, REDNESS, WARMTH AND PAIN, CELLULITIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CELLULITIS AND PURULENT DRAINAGE LEFT SHOULDER WOUND</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER ANTERIOR INCISIONS WITH MILD CELLULITIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INFECTION/SMALL HEMATOMA</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>RIGHT SHOULDER DISCOMFORT SECONDARY TO FALL</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>FALL CAUSING RIGHT SHOULDER FORCED ABDUCTION</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ROTATOR CUFF SPRAIN/STRAIN LEFT SHOULDER</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ROTATOR CUFF SPRAIN/STRAIN RIGHT SHOULDER</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INCREASED RIGHT SHOULDER PAIN R/T FALL</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER INCREASED PAIN AND STIFFNESS R/T CATCHING FALLING CLIENT</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT ANKLE SPRAIN WITH SWELLING AND PAIN R/T FALL</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER IMPINGEMENT SYNDROME, WITH LIMITED ADLS AND NIGHT PAIN</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT RTC SMALL PARTIAL THICKNESS TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER EDEMA</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RECURRENT RTC TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>WORSENING LEFT SHOULDER PAIN AND SWELLING DUE TO FALLING IN SHOWER, CATCHING HERSELF WITH LEFT ARM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT ROTATOR CUFF TENDONITIS, ACJ IMPINGEMENT</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>SLIPPED OFF CURB AND FELL ONTO LEFT ARM</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PAIN FROM LEFT SHOULDER STRAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER SURGICAL SCAR SENSITIVITY</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>REDNESS AND SWELLING AROUND INCISION FRONT OF RIGHT SHOULDER</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT BICIPITAL GROOVE TENDERNESS AFTER OVERSTRETCHING IN PT</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CONTINUED POST-OP REVISION LEFT SHOULDER PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>POSSIBLE LEFT CUBITAL TUNNEL SYNDROME</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER PAIN POST MUA, LOA</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT ROTATOR CUFF RE-TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ROTATOR CUFF RETEAR</sub_title>
                <description>Unlikely related to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT ELBOW INJURY, POSSIBLE FRACTURE, OCCURRED DUE TO FALL</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ROTATOR CUFF FAILURE / RECURRENT TEAR</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>LEFT SHOULDER TENDINITIS/BURSITIS</sub_title>
                <description>Unlikely related to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ADHESIVE CAPSULITIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>BICEPS ATROPHY</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ADHESIVE CAPSULITIS RIGHT SHOULDER</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT BICEPS TENDONITIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER ADHESIVE CAPSULITIS POST RCR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PAINFUL HERNIATED CERVICAL DISC WITH MYELOPATHY</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>BICEPS TENDONITIS RIGHT SHOULDER</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT LATERAL EPICONDYLITIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT TRICEPS TENDONITIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>NOCTURNAL AWAKENING DUE TO RIGHT SHOULDER TENDINOSIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>SMALL PARTIAL THICKNESS LEFT SUPRASPINATUS TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DISCOMFORT RIGHT BICEP INTO NECK AND DISUSE ATROPHY</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER BURSITIS WITH DECREASED ROM AND WEAKNESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER MILD TENDINOSIS, POSSIBLE SLAP TEAR</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PALPABLE TIGHTNESS RIGHT TRAPEZIUS AREA</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>GLENOHUMERAL INTERNAL ROTATION DEFICIT RIGHT SHOULDER</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT SHOULDER STIFFNESS</sub_title>
                <description>Possibly related to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT KNEE ARTHROFIBROSIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEFT ELBOW STIFFNESS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RIGHT SHOULDER MUSCLE SPASMS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>MASS OF SOFT TISSUE OF RIGHT UPPER EXTREMITY</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>ULNAR NERVE SYMPTOMS AND MEDIAL SCAPULAR PAIN, NECK PAIN</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HERNIATED DISC WITH MYELOPATHY</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>SEVERE CENTRAL SPINAL STENOSIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>NIGHTMARES FROM PERCOCET</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>GENERALIZED ANXIETY DISORDER</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ADD</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>LEFT SHOULDER ANTERIOR PORTAL REDDENED AND SWOLLEN WITH RESOLVING BICEP ECCHYMOSIS</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RAISED RASH RIGHT FOREARM AND RIGHT ARMPIT</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HERPES ZOSTER</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>EXACERBATION HYPERTENSION</sub_title>
                <description>Unrelated to device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>No limitations reported</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Judith Horner</name_or_title>
      <organization>Smith+Nephew, Inc.</organization>
      <phone>+44 1482 673251</phone>
      <email>Judith.horner@smith-nephew.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03826667
org study id: 2018.16.SMD.PEEK.RET.SHD
nct id: NCT03826667
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.
observational model: Case-Only
time perspective: Retrospective
measure: Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
time frame: 6 months
description: Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
no inflammatory or allergic response
no device-related adverse event (AE)
no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
measure: Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
time frame: 12 months
description: Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
no inflammatory or allergic response
no device-related adverse event (AE)
no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
measure: Visual Analog Scale (VAS) - Pain
time frame: 6 and 12 months
description: The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.
measure: Count of Participants With Range of Motion (ROM) Full Functional Arc
time frame: 6 and 12 months
description: Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits.
measure: Range of Motion (ROM)
time frame: 6 and 12 months
description: Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.
intervention type: Device
intervention name: Polyetheretherketone (PEEK) Shoulder Suture Anchors
description: PEEK Suture Anchors, which include:
HEALICOIL™ PK Preloaded Suture Anchors
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors
BIORAPTOR™ Knotless Suture Anchors
MULTIFIX™ S Ultra Knotless Fixation System
FOOTPRINT™ Ultra PK Suture Anchors
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles
SPEEDSCREW™ Knotless Fixation System
SpeedLock Knotless Fixation Device
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Judth Horner
role: Study Chair
affiliation: Smith & Nephew, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: No limitations reported
point of contact: 