BEUDAMED
    FDA Adverse Event Injury Summary report: N

    END CAP, TI +5 MM

    MDR report key: 1780792 · Received July 27, 2010

    Report

    Report Number
    9610622-2010-00317
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 12, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT UNDERWENT THE SURGERY WITH THE G3 TROCHANTERIC NAIL. AFTER TWO WEEKS THE SURGEON CONFIRMED BY X-RAY THAT THE END CAP WAS LOOSING. THE END CAP WAS REVISED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 END CAP, TI +5 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K956253

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention