BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER INSTRUMENT

    MDR report key: 1170751 · Received September 15, 2008

    Report

    Report Number
    1644408-2008-00323
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 8, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THREADS BROKE OFF IN GLENOSPHERE HEAD DURING IMPACTION. SURGEON REMOVED THE HEAD AND THE ENTIRE BASEPLATE AND SCREWS CAME OUT ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER INSTRUMENT GLENOID HEAD INSTERTER/IMPACTOR HWA ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other