BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G/K TB LOCKING NAIL USA D10XL285

    MDR report key: 3659019 · Received March 5, 2014

    Report

    Report Number
    0009610622-2014-00105
    Event Type
    Injury
    Date Received
    March 5, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K860756
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SURGEON REPORTED VIA THE STRYKER DISTRIBUTOR IN (B)(6) THAT THE G&K NAIL WAS FOUND TO BE BROKEN. PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131993 G/K TB LOCKING NAIL USA D10XL285 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention