BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD SPINAL FIXATION SYSTEM

    MDR report key: 224157 · Received May 19, 1999

    Report

    Report Number
    1030489-1999-00066
    Event Type
    Injury
    Date Received
    May 19, 1999
    Date of Event
    September 11, 1992
    Report Date
    April 20, 1999
    Manufacturer
    SOFAMOR DANEK EUROPE
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 10/08/1990. POST OPERATIVE X-RAYS TAKEN ON 01/03/1991 REVEAL THAT THE ROD HAS SEPARATED FROM THE SCREW AT L3. IT WAS NOTED THAT THIS HAD NO EFFECT ON THE FUSION. REVISION SURGERY ON 09/11/1992 TO REMOVE DEVICE DUE TO "PROGRESSIVELY INCREASING BACK PAIN" OVER THE PRECEDING MONTHS. IT WAS NOTED THAT THERE WAS SOLID FUSION.

    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 65 YR Required Intervention