BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R 1.5, TI, RIGHT GAMMA3 10 X 300 MM X 1

    MDR report key: 2680954 · Received July 31, 2012

    Report

    Report Number
    9610622-2012-00318
    Event Type
    Injury
    Date Received
    July 31, 2012
    Date of Event
    June 20, 2012
    Report Date
    July 6, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICE: 3060-0100S LANG SCREW, TI GAMMA3 10.5 X 100 MM, (B)(4) LOT. (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5 X 35 MM K245266 LOT. (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5 X 35 MM, K665296 LOT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT THE SURGERY WITH A G3 LONG NAIL. ABOUT ONE YEAR AFTER, THE SURGEON FOUND THROUGH X-RAY THAT THE NAIL WAS BROKEN. THE PT UNDERWENT REVISION SURGERY AND HAD A BHA ON (B)(6) 20212. THIS CASE WAS SUBTROCHANTERIC FRACTURE BY THE TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R 1.5, TI, RIGHT GAMMA3 10 X 300 MM X 1 IMPLANT HSB STRYKER OSTEOSYNTHESIS - KIEL NA K990828

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention