BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX LONG

    MDR report key: 2211989 · Received August 5, 2011

    Report

    Report Number
    1719045-2011-00537
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    NKB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    DURING A SPINAL FUSION L4-L5 PROCEDURE, THE SURGEON FINALLY TIGHTENED THE LOCKING CAPS AND THEN DECIDED TO MOVE THE ROD. SURGEON WAS TRYING TO REMOVE THE LOCKING CAP AT L5 AND THE TIP OF THE T-25 STARDRIVE SHAFT F/MATRIX BROKE IN THREE PIECES. TWO OF THE PIECES WERE RETRIEVED, THE THIRD PIECE WAS COLD WELDED ONTO THE RECESS OF THE LOCKING CAP AND REMAINS IN THE PT. SURGEON COULD NOT REMOVE THE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T25 STARDRIVE SHAFT F/MATRIX LONG T25 STARDRIVE SHAFT NKB SYNTHES MONUMENT 6457222

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW