BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE

    MDR report key: 443019 · Received February 10, 2003

    Report

    Report Number
    MW1027516
    Event Type
    Injury
    Date Received
    February 10, 2003
    Date of Event
    January 24, 2000
    Report Date
    February 10, 2003
    Manufacturer
    SPINE TECH
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SPINAL FUSION AT L5/S1 USING SILHOUETTE-BAK-DEVICE MANUFACTURED BY SULZER/SPINETECH. ONE OF THE PEDICLE SCREWS FAILED TO LOCK INTO PLACE AND THE SURGEON NEVER INFORMED THE PT THAT SPINE TECH HAD RECALLED THE SAME DEVICES IN 9/01. THE SURGEON NEVER ENTERED IN THE SURGICAL SERIAL NUMBERS OR EVEN THE TYPE OF UNIT. THE PT'S SURGEON HAD TO CONTACT THE DR. TO FIND OUT WHAT TYPE OF TOOLS WERE NEEDED TO REMOVE THE APPLIANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE BACK FUSION DEVICE APPROVED BY FDA IN 1996 MCV SPINE TECH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability