BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X260MM X 12

    MDR report key: 2743256 · Received September 6, 2012

    Report

    Report Number
    9610622-2012-00391
    Event Type
    Injury
    Date Received
    September 6, 2012
    Date of Event
    August 13, 2012
    Report Date
    August 15, 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 ADDITIONAL INFORMAITON WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: 3060-0085S LAG SCREW, TI GAMMA3 10.5X85MM LOT NO. K646131; 18965-035S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X35 MM LOT# K910009; 18965-040S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM LOT# K429408.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT THE SURGERY WITH THE G3 LONG NAIL. ABOUT 9 MONTHS AFTER, THE SURGEON FOUND THROUGH THE X-RAY THAT THE NAIL WAS BROKEN. THEREFORE, THE SURGEON IS PLANNING REVISION SURGERY BY BHA ON (B)(6). THE SURGEON REQUESTED THE INVESTIGATION OF THE REMOVED IMPLANTS. THIS PATIENT HAS BONE TUMORS AND THE FRACTURE PART WAS NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X260MM X 12 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K904247

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R