BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE SPINAL SYSTEM

    MDR report key: 279169 · Received May 23, 2000

    Report

    Report Number
    2184052-2000-00004
    Event Type
    Injury
    Date Received
    May 23, 2000
    Date of Event
    April 19, 2000
    Report Date
    May 23, 2000
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RODS BECAME LOOSE AT L5 BILATERALLY, APPROXIMATELY THREE WEEKS AFTER IMPLANTATION. THE CONSTRUCT WAS EXPLANTED AND THE PT WAS REVISED WITH ANOTHER PEDICLE SCREW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE SPINAL SYSTEM SPINAL FIXATION DEVICE KWP SULZER SPINE-TECH NA P990197

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention