BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1171251 · Received September 19, 2008

    Report

    Report Number
    1030489-2008-00533
    Event Type
    Injury
    Date Received
    September 19, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE USING COUNTER TORQUE WRENCH TO BREAK OF THE SETSCREW IN 2008. WHILE THE SURGEON WAS TWISTING OFF A LOCKING SCREW, THE COUNTER TORQUE WRENCH DETACHED FROM THE SCREW TAB AND DAMAGED THE DURA MATER. THE SURGEON REPAIRED THE DURA MATER. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT COUNTER TORQUE LXH MEDTRONIC SOFAMOR DANEK NA MD04A002

    Patients

    Seq Age Sex Outcome Treatment
    1