BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER INSTRUMENT

    MDR report key: 2193575 · Received July 14, 2011

    Report

    Report Number
    1644408-2011-00398
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE/END OF LIFE - THE TRIAL BROKE WHEN IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER INSTRUMENT HUMERAL SOCKET INSERT TRIAL HSD ENCORE MEDICAL, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR