BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U-BLADE SET, TI GAMMA3 10.5X90MM

    MDR report key: 2869619 · Received November 30, 2012

    Report

    Report Number
    9610622-2012-00548
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    June 29, 2012
    Report Date
    November 14, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS 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

    THIS CASE WAS PRESENTED AT (B)(6) ON (B)(6) 2012. DEVIATIONS IN THE MANUFACTURING DOCUMENTS OF BOTH LAG SCREW AND NAIL KIT WERE NOT FOUND. THE REPORTED ITEMS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. EXAMINATION OF THE AFFECTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED FOR INVESTIGATION (POSSIBLE DISCARDED). ADDITIONAL DEVICES: (B)(4) TROCHANTERIC NAIL KIT, TI GAMMA3 10 X 170 MM X 130 LOT # K157023; (B)(4) LAG SCREW END CAP, TI GAMMA3 10.5 +1.5 MM LOT # K524697; (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5X35 MM LOT# K119516; (B)(4) END CAP, STD, TI GAMMA3 LOT #K123968.

    Description of Event or Problem · 1

    FIVE MONTHS AFTER OF THE PRIMARY G3 SURGERY, THE PT HAD PAIN AND IT BECAME DIFFICULT TO WALK. BECAUSE THE LAG SCREW HAD CUT OUT THE EXTRACTION OF THE LAG SCREW WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-BLADE SET, TI GAMMA3 10.5X90MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K271976

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Other| R