BEUDAMED
    FDA Adverse Event Summary report: N

    SILHOUETTE SPINAL FIXATION SYSTEM

    MDR report key: 285304 · Received July 6, 2000

    Report

    Report Number
    2184052-2000-00007
    Date Received
    July 6, 2000
    Date of Event
    June 7, 2000
    Report Date
    July 6, 2000
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    KWQ
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SILHOUETTE PEDICLE SCREW CONSTRUCT WAS IMPLANTED FROM L3 TO L5, ALONG WITH AUTOGRAFT AND CANCELLOUS BONE CHIPS. DURING A FOLLOW-UP EXAMINATION, IT WAS NOTICED THAT THE SCREWS IN THE L5 PEDICLES HAD BEEN BROKEN MID-SHAFT. THE PT REMAINS ASYMPTOMATIC AND IS REPORTEDLY PLEASED WITH THE POST-OPERATIVE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other