BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILHOUETTE SPINAL FIXATION SYSTEM

    MDR report key: 496338 · Received November 14, 2003

    Report

    Report Number
    2184052-2003-00016
    Event Type
    Other
    Date Received
    November 14, 2003
    Date of Event
    August 27, 2002
    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

    SURGERY WAS PERFORMED IN 2001. TWO LEVEL POLAR CASE WITH TWO 13X20MM BAK/L IMPLANTS, LOT 990657, IMPLANTED AT L4-S1. A TWO LEVEL BILATERAL SILHOUETTE CONSTRUCT WAS ALSO IMPLANTED CONSISTING OF TWO 6.5 X 45MM POLYAXIAL PEDICLE SCREWS, TWO 6.5 X 50MM SCREWS, TWO 7.5 X 50MM SCREWS, SIX LOCKING NUTS AND 5.5MM STAINLESS STEEL ROD.

    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 * Other