BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPUS / AUTO CUFF

    MDR report key: 751539 · Received September 2, 2005

    Report

    Report Number
    MW1036537
    Event Type
    Other
    Date Received
    September 2, 2005
    Date of Event
    August 22, 2005
    Report Date
    August 24, 2005
    Manufacturer
    ARTHROCARE
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AUTO CUFF IMPLANTED IN (L) SHOULDER. BROKEN TAC REMOVED FROM JOINT (L) SHOULDER 2 MOS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPUS / AUTO CUFF SHOULDER TACK MBI ARTHROCARE * 107299

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other