BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125

    MDR report key: 2777563 · Received October 1, 2012

    Report

    Report Number
    9610622-2012-00447
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 20, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: 3060-0095S LAG SCREW, TI GAMMA3 10.5X95MM LOT# K771556. 3005-1100S END CAP, STD, TI GAMMA3 LOT# K902347 1796-5035S LOCKING SCREW, FULLY THREADED S2 5X35 MM LOT# K434994.

    Description of Event or Problem · 1

    IMPLANT SURGEON OF THE HOSPITAL REPORTED TO OUR SALES REP THAT A PATIENT CAME IN WITH PAIN. HE TOOK SOME X-RAYS AND OBSERVED THAT THE NAIL IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K706461

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R