BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD SPINAL FIXATION SYSTEM

    MDR report key: 224661 · Received May 19, 1999

    Report

    Report Number
    1030489-1999-00062
    Event Type
    Malfunction
    Date Received
    May 19, 1999
    Date of Event
    April 28, 1997
    Report Date
    April 20, 1999
    Manufacturer
    SOFAMOR DANEK EUROPE
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 05/18/1993. PATIENT COMPLAINED OF PAIN. POST OPERATIVE X-RAY REPORT ON 04/28/1997 STATES THAT "THE LOWER SCREW IS IN THE L4-5 DISC SPACE". NOT REPORTED TO HAVE BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD SPINAL FIXATION SYSTEM Implant SPINAL FIXATION SYSTEM KWP SOFAMOR DANEK EUROPE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR