BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE SPINAL SYSTEM

    MDR report key: 221497 · Received April 30, 1999

    Report

    Report Number
    2184052-1999-00003
    Event Type
    Injury
    Date Received
    April 30, 1999
    Date of Event
    April 2, 1999
    Report Date
    April 30, 1999
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO WEEKS POSTOPERATIVELY, THE ROD PULLED LOOSE FROM THE POLYAXIAL SCREW. IT APPEARS THE NUT ON THE SCREW WAS CROSS-THREADED. A REVISION SURGERY WAS PERFORMED; THE LEFT ROD AND SCREWS AND THE SCREW IN THE RIGHT LUMBAR 4 PEDICLE WERE REMOVED LEAVING A UNILATERAL CONSTRUCT FROM LUMBAR 5 TO SACRAL 1. BONE WAS PACKED IN THE LUMBAR 5 TO SACRAL 1 DISC SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE SPINAL SYSTEM Implant SPINAL FIXATION DEVICE KWP SULZER SPINE-TECH NA P980174

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention