BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILHOUETTE SPINAL FIXATION SYSTEM

    MDR report key: 496762 · Received November 20, 2003

    Report

    Report Number
    2184052-2003-00017
    Event Type
    Other
    Date Received
    November 20, 2003
    Date of Event
    November 20, 2002
    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

    SURGERY WAS PERFORMED ON PATIENT ON OR ABOUT 2002. THE SURGICAL SITE WAS L4-S1. THE FOLLOWING ITEMS WERE IMPLANTED: TWO 17 X 20MM BP/LORDIOTIC INTERBODY IMPLANTS (CAGES), LOT P990452; ONE 6.5 X 50 MM POLYAXIAL PEDICLE SCREW, ONE 6.5 X 55 MM POLYAXIAL PEDICLE SCREW, TWO 7.5 X 50 MM POLYAXIAL PEDICLE SCREWS, ONE 7.5 X 55 MM POLYAXIAL PEDICLE SCREW, ONE 8.5 X 40 MM POLYAXIAL PEDICLE SCREW, STAINLESS STEEL ROD, ADN SIX LOCKING NUTS. CENTERPULSE SPINE-TECH WAS NOTIFIED THAT ON OR ABOUT 2002, PATIENT WAS INJURED BY THE SILHOUETTE SPINAL FIXATION SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other