BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1941229 · Received December 29, 2010

    Report

    Report Number
    1030489-2010-01656
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A POSTERIOR FIXATION SPINAL PROCEDURE AT T12-L3. THE PEDICLE SCREWS WERE IMPLANTED, X10 CROSSLINK WAS ALSO IMPLANTED AT L1-L2. THE IMPLANTED CROSSLINK APPEARED TO BE TOO BIG IN THE PATIENT, IT WAS DECIDED TO BE REMOVED USING THE REMOVAL DRIVER. WHILE OPERATING CROSSLINK REMOVAL, THE TIP OF THE DRIVER BROKE AND STUCK INTO THE X10 CROSSLINK'S SET SCREW. THE POSTERIOR PLUGS HAD TO BE REMOVED TO DISPLACE THE ROD THAT HAD THE X10 CROSSLINK ATTACHED. THE ROD IMPLANTATION WAS STARTED OVER. NO CROSSLINK WAS IMPLANTED IN THE PATIENT. THE REST OF THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING ID05F001

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR