BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE SPINE INSTRUMENT

    MDR report key: 1220525 · Received October 29, 2008

    Report

    Report Number
    1644408-2008-00380
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 2, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    EXPANDING CAGE LOCKING WRENCH STRIPPED INNER THREADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE SPINE INSTRUMENT WRENCH, LOCKING HXC ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention