BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE SPINAL FIXATION SYSTEM

    MDR report key: 283697 · Received June 27, 2000

    Report

    Report Number
    2184052-2000-00006
    Event Type
    Injury
    Date Received
    June 27, 2000
    Date of Event
    May 30, 2000
    Report Date
    June 26, 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

    WHILE TIGHTENING THE PEDICLE SCREW CONSTRUCT AT L5-S1, THE RIGHT S1 PEDICLE WAS FRACTURED. THE IMPLANTS WERE REMOVED ON THE RIGHT SIDE, LEAVING A UNILATERAL CONSTRUCT ON THE LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWP SULZER SPINE-TECH NA P000345

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention BAK INTERBODY IMPLANT.