BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILHOUETTE SPINAL FIXATION SYSTEM

    MDR report key: 301469 · Received October 20, 2000

    Report

    Report Number
    2184052-2000-00012
    Event Type
    Other
    Date Received
    October 20, 2000
    Date of Event
    September 22, 2000
    Report Date
    October 20, 2000
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    KWP
    Adverse Event
    Yes
    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 AT L5-S1. DURING A FOLLOW-UP EXAMINATION APPROXIMATELY SEVEN WEEKS POST-OP, IT WAS NOTICED THAT THE RIGHT SACRAL SCREW HAD BEEN BROKEN MID-SHAFT. THERE HAS BEEN NO CHANGE IN THE PT'S CONDITION SINCE THE CONSTRUCT WAS IMPLANTED. THE SURGEON HAS NO PLANS TO RE-OPERATE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other