BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE SPINAL SYSTEM

    MDR report key: 278139 · Received May 16, 2000

    Report

    Report Number
    2184052-2000-00002
    Event Type
    Injury
    Date Received
    May 16, 2000
    Date of Event
    February 1, 2000
    Report Date
    May 15, 2000
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PEDICLE SCREWS AT S1 WERE ANGLED POSTERIORLY UPON INSERTION. THIS RESULTED IN DIFFICULTY TIGHTENING THE LOCKING NUTS ON THE SACRAL SCREWS, AS THE HEADS OF THE SCREWS AT S1 WERE EXTREMELY CLOSE TO THE HEADS OF THE SCREWS AT L5. SPONDYLOLISTHESIS AT L5-S1 ALSO CONTRIBUTED TO THE DIFFICULT IN TIGHTENING THE LOCKING NUTS. THE PATIENT WAS CLOSED, ALTHOUGH IT COULD NOT BE VERIFIED THAT THE LOCKING NUTS WERE SUFFICIENTLY TIGHT, DUE TO THE PROXIMITY OF THE SCREWS. TWO TO THREE DAYS POST-OP, THE RODS BECAME LOOSE. A RE-OPERATION WAS PERFORMED TO REMOVE THE CONSTRUCT AND REPLACE 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention ANTERIOR LUMBAR INTERBODY FUSION.