BEUDAMED
    FDA Adverse Event Summary report: N

    G/K FEMORAL NAIL

    MDR report key: 499757 · Received December 4, 2003

    Report

    Report Number
    9610622-2003-00050
    Date Received
    December 4, 2003
    Date of Event
    January 12, 2002
    Report Date
    November 6, 2003
    Manufacturer
    STRYKER HOWMEDICA KIEL TRAUMA GMBH
    Product Code
    JDS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A GK NAIL LEFT FEMUR, IN 2002. THE CUSTOMER STATED PSEUDARTHROSIS AND THEN THE NAIL FRACTURE IN 2002. FOLLOWING THIS EVENT, THE NAIL WAS REMOVED AND ANOTHER SIMILAR NAIL WAS IMPLANTED IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G/K FEMORAL NAIL IMPLANT JDS STRYKER HOWMEDICA KIEL TRAUMA GMBH NA K605220

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention