BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILHOUETTE SPINAL FIXATION SYSTEM

    MDR report key: 496359 · Received November 14, 2003

    Report

    Report Number
    2184052-2003-00015
    Event Type
    Other
    Date Received
    November 14, 2003
    Date of Event
    March 6, 2001
    Report Date
    November 14, 2003
    Manufacturer
    CENTERPULSE SPINE-TECH
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT UNDERWENT A LUMBAR DECOMPRESSION, AS WELL AS POSTERIOR SPINAL FUSION, IN 2000. IMPLANTED A BILATERAL ONE LEVEL CONSTRUCT AT L5-S1 CONSISTING OF TWO 6.5 X 35MM PEDICLE SCREWS, TWO 6.5 X 40MM PEDICLE SCREWS, FOUR LOCKING NUTS AND 5.5MM STAINLESS STEEL ROD. IN 2000, FOUR MONTHS POST-OP, PT REPORTED TO THEIR SURGEON THAT PT HAD FALLEN TO THEIR KNEES. THE SURGEON PERFORMED A SCAN AND TOOK AN X-RAY IMAGE THAT SHOWED CONTINUED NON-UNION OF THEIR BONES, BUT NO APPARENT FRACTURE IN THE SCREWS. PT'S SYMPTOMS DID NOT IMPROVE MUCH AFTER THE SURGERY. A CT SCAN PERFORMED IN 2001, 9 MONTHS POST-OP, REVEALED THE FRACTURE OF TWO OF THE FOUR SCREWS. IN 2001, A DIFFERENT SURGEON REMOVED THE PEDICLE SCREW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE SPINAL FIXATION SYSTEM SILHOUETTE FIXED PEDICLE SCREW MCV CENTERPULSE SPINE-TECH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other BONE GRAFT WAS IMPLANTED.