BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITST FIXATION NAIL - ASIA

    MDR report key: 1841987 · Received August 31, 2010

    Report

    Report Number
    2648920-2010-00038
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ZIMMER
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN THE SURGEON REMOVED THE DEVICE AFTER UNION, IT WAS OBSERVED THAT THE FEMORAL NAIL HAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITST FIXATION NAIL - ASIA TRAUMA PROSTHESIS JDS ZIMMER 61079838

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR