BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 120

    MDR report key: 2910738 · Received January 8, 2013

    Report

    Report Number
    9610622-2013-90014
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    August 18, 2012
    Report Date
    December 19, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032579
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THE DEVICE FOR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. CONCOMITANT DEVICES: 3060-0100S LAG SCREW, TI GAMMA3 10.5X100MM LOT# K898289; 1896-5042S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X42.5 MM LOT# K595838, AND LOT# K137488.

    Description of Event or Problem · 1

    IT IS REPORTED BY OUR CA BFARM THAT A USER REPORTED A BROKEN GAMMA NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8921 TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 120 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K929415

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R