BEUDAMED
    FDA Adverse Event Other Summary report: N

    TISSUETAK II, 5MM HEAD, STRAIGHT

    MDR report key: 539019 · Received August 16, 2004

    Report

    Report Number
    1220246-2004-00022
    Event Type
    Other
    Date Received
    August 16, 2004
    Date of Event
    March 3, 2004
    Report Date
    August 16, 2004
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TISSUE TAK HEAD BROKE OFF POST OP. PT WAS BROUGHT BACK FOR POST OP PAIN FOLLOWING SLAP REPAIR OF RIGHT SHOULDER. WHEN ARTHROSCOPY WAS PERFORMED A TISSUE TAK HEAD AND 1/4 OF TAK BODY WAS FOUND FLOATING LOOSE IN JOINT SPACE. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSUETAK II, 5MM HEAD, STRAIGHT BIO-IMPLANT KWR ARTHREX, INC. AR-1935B 29398

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention