BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE SPINAL FIXATION SYSTEM

    MDR report key: 286665 · Received July 20, 2000

    Report

    Report Number
    2184052-2000-00008
    Event Type
    Injury
    Date Received
    July 20, 2000
    Date of Event
    June 14, 2000
    Report Date
    July 20, 2000
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SILHOUETTE CONSTRUCT HAD BEEN IMPLANTED, WITH PEDICLE SCREWS PLACED AT L4 AND S1. DURING A F/U EXAM APPROXIMATELY 11 WEEKS POST-OP, IT WAS NOTICED THAT THE TWO SCREWS IN THE S1 PEDICLES HAD BEEN BROKEN MID-SHAFT. REVISION SURGERY WAS PERFORMED, AS THE PT REPORTED BACK PAIN. THE BROKEN SCREWS AT S1 WERE REMOVED AND REPLACED WITH LARGER SCREWS. IN ADDITION, PEDICLE SCREWS WERE PLACED AT L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWP SULZER SPINE-TECH NA P990598

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention AND L5-S1 WITH BAK INTERBODY IMPLANTS (2000).| OPEN ANTERIOR LUMBAR INTERBODY FUSION AT L4-L5,