BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI 11X200MM X120

    MDR report key: 1932998 · Received December 10, 2010

    Report

    Report Number
    9610622-2010-00533
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 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
    SZ
    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 BY THE SURGEON IN HIS E-MAIL TO OUR SALES REP, ABOUT A BROKEN LONG GAMMA NAIL. THE NAIL WAS IMPLANTED IN JULY AFTER THE PATIENT HAD FALLEN AND SUFFERED FROM A FEMUR FRACTURE. ACCORDING TO THE SURGEON, FULL WEIGHT BEARING AFTER 3 MONTHS, HEALING PROCESS WITHOUT PROBLEMS, NOW THE BREAKAGE OF THE NAIL WITHOUT ADDITIONAL TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI 11X200MM X120 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention