BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILHOUETTE SPINAL FIXATION SYSTEM

    MDR report key: 496748 · Received November 20, 2003

    Report

    Report Number
    2184052-2003-00019
    Event Type
    Other
    Date Received
    November 20, 2003
    Date of Event
    July 31, 2001
    Report Date
    November 20, 2003
    Manufacturer
    CENTERPULSE SPINE-TECH
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A LUMBAR LAMINECTOMY WITH POSTEROLATERAL LUMBAR FUSION FROM L3 TO S1 IN 2001. THE FOLLOWING ITEMS WERE IMPLANTED: SILHOUETTE 5.5MM STEEL RODS. TRANSVERSE CONNECTORS, (4), LOCKING NUTS/INSERTS, EIGHT LOCKING NUTS, FOUR 5.5 X 40MM POLYAXIAL SCREWS, TWO 6.5 X 50MM POLYAXIAL SCREWS, AND TWO 64 X 45MM POLYAXIAL SCREWS. ACCORDING TO X-RAYS TAKEN IN 2001 ONE OF THE SCREWS HAD FRACTURED. THE REMAINING CONSTRUCT WAS IN PROPER POSITION. THE FIXATION SYSTEM WAS REMOVED (5 1/2 MONTHS POST-OP). HALF OF THE BROKEN SCREW WAS NOT TO BE REMOVED AND CURRENTLY REMAINS IMPLANTED IN THE PATIENT'S VERTEBRAL BONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN