BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAM NAIL LONG RIGHT

    MDR report key: 544807 · Received September 11, 2004

    Report

    Report Number
    9610622-2004-00038
    Event Type
    Injury
    Date Received
    September 11, 2004
    Date of Event
    February 20, 2004
    Report Date
    August 17, 2004
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    KTT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE IMPLANT SURGEON THE GAMMA NAIL BROKE 7 YEARS AFTER THE IMPLANTATION. PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAM NAIL LONG RIGHT IMPLANT KTT STRYKER TRAUMA KIEL NA 305334

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention