BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U-BLADE SET, TI GAMMA3 10.5X100MM

    MDR report key: 2885225 · Received December 18, 2012

    Report

    Report Number
    9610622-2012-00592
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 6, 2012
    Manufacturer
    STRYKER OSETOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES, 3125-0170S TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125 LOT# K270848; 3005-1100S END CAP, STD, TI GAMMA3 K133620; 1896-5040S LOCKING SCREW, FULLY THREADED T2 TIBIA; 5X40 MM LOT# K389960.

    Description of Event or Problem · 1

    ON 2012 (B)(6) GAMMA3 SURGERY WAS PERFORMED. THEN THE PENETRATION OF LAG SCREW WAS CONFIRMED 9 MONTHS AFTER THE SURGERY. ON 2012 (B)(6), REVISION TO GAMMA3 LONG NAIL WAS PERFORMED. THE CUSTOMER REQUESTS VERIFICATION OF WHETHER THE SET SCREW WAS INSTALLED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-BLADE SET, TI GAMMA3 10.5X100MM IMPLANT HSB STRYKER OSETOSYNTHESIS KIEL NA K573885

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R