BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 120

    MDR report key: 2910429 · Received January 8, 2013

    Report

    Report Number
    9610622-2013-90015
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    October 24, 2012
    Report Date
    December 19, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. CONCOMITANT MEDICAL PRODUCTS: 1896-5037S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X37, 5MM LOT# K104950, LOT#K115907; 3060-008S LAG SCREW, TI GAMMA3 10.5X80MM LOT#K149984; 6704-4-016 VIT CABLE CRIMP SLEEVE 1.6MM LOT# 38749501; 6704-8-236 DALL MILES VIT 1.6MM CABLE, LOT# 38656402.

    Description of Event or Problem · 1

    IT IS REPORTED BY CA BFARM THAT THEY RECEIVED A USER REPORT OF A BROKEN GAMMA NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9844 TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 120 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K929670

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R