BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILHOUETTE SPINAL FIXATION SYSTEM

    MDR report key: 496755 · Received November 20, 2003

    Report

    Report Number
    2184052-2003-00018
    Event Type
    Other
    Date Received
    November 20, 2003
    Date of Event
    October 9, 2000
    Report Date
    November 20, 2003
    Manufacturer
    CENTERPULSE SPINE-TECH, INC.
    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 SURGERY IN 1999. A DECOMPRESSIVE LAMINECTOMY WAS PERFORMED AT L4 AND L5 WITH POSTERIOR INTERBODY FUSION AND FIXATION. A POSTERIOR ILIAC CREST BONE HARVEST WAS ALSO PERFORMED. THE FOLLOWING ITEMS WERE IMPLANTED: 13 X 24MM BAK/L CAGE, LOT P980081; 11 X 24 MM BAK/L, LOT P970230; FOUR (4) LOCKING NUTS, LOT P98017; 6.5 X 40MM POLY SCREWS, LOT P990312, 6.5 X 45MM POLY SCREWS, LOT P990130; 5.5 MM STAINLESS STEEL ROD, LOT 980513. IN 2000 (13 MONTH'S POST-OP), X-RAY IMAGES ALLEGEDLY REVEALED THAT THE PEDICLE SCREWS WERE FRACTURED. TWO WEEKS LATER, THE BROKEN SCREWS WERE ALLEGEDLY REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN