BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI 11X200MM X 125

    MDR report key: 1211121 · Received October 23, 2008

    Report

    Report Number
    9610622-2008-00200
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 30, 2008
    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 INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA OUR SALES REP, THAT A FEMALE PATIENT UNDERWENT A REVISION SURGERY, DUE TO THE NAIL FRACTURING 4 MONTHS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI 11X200MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL UNK K617730

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention