BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEAR SHIFT

    MDR report key: 1162803 · Received September 16, 2008

    Report

    Report Number
    MW5008320
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 15, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNDERGOING THE FOLLOWING PROCEDURES: REMOVAL OR L2-L5 INSTRUMENTATION; T12-L2 LAMINECTOMY POSTERIOR SPINAL FUSION; TRANSFORAMINAL LUMBAR INTRABODY FUSION CAGE; T12 SACRUM INSTRUMENTATION. TIP OF "GEAR SHIFT" DEVICE BROKE OFF AT 20 CM MARK AND BECAME LODGED IN PATIENT'S VERTEBRA. (THIS DEVICE IS USED TO MAKE AN INDENTATION INTO BONE PRIOR TO THE INSERTION OF PEDICLE SCREWS.) THE SURGEON STATED THE DEVICE WAS NOT LODGED NEAR ANY ORGANS, VESSELS OR NERVES, AND THUS MADE A DECISION TO ALLOW IT TO REMAIN INSIDE THE PT. DATES OF USE: 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEAR SHIFT GEAR SHIFT LXH MEDTRONIC 7480110 7480110

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR