BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR ACTOSCREW WHITE MAXBRAID

    MDR report key: 957535 · Received November 13, 2007

    Report

    Report Number
    957535
    Event Type
    Injury
    Date Received
    November 13, 2007
    Date of Event
    October 1, 2007
    Report Date
    October 4, 2007
    Manufacturer
    ARTHROTEK, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RIGHT SHOULDER PAIN WITH PARTIAL TEAR OF THE ROTATOR CUFF. PER SURGEON, PT WAS DOING WELL UNTIL SHE THREW A TENNIS BALL HARD AND HAS HAD SIGNIFICANT PAIN SINCE THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR ACTOSCREW WHITE MAXBRAID OPUS ANCHOR X 1 HWC ARTHROTEK, INC. * 639260

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization