BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR HIP INSTRUMENTATION

    MDR report key: 1170750 · Received September 15, 2008

    Report

    Report Number
    1644408-2008-00320
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 21, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    HIP INSTRUMENTATION - BROACH HANDLE IS LOOSE ON THE BROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR HIP INSTRUMENTATION HANDLE, BROACH, LATERAL HTQ ENCORE MEDICAL, L.P. 34556L02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other