BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI 11X180MM X 125

    MDR report key: 1844874 · Received September 22, 2010

    Report

    Report Number
    9610622-2010-00396
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 10, 2010
    Report Date
    September 7, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HEADSURGEON REPORTS VIA OUR SALES REP, THAT THE NAIL BROKE 5 WEEKS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI 11X180MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K231028

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention