BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER

    MDR report key: 1935403 · Received November 17, 2010

    Report

    Report Number
    1644408-2010-00611
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT END OF LIFE - INSTRUMENT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER TWO PIECE DRILL GUIDE FZX ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR