BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD SPINAL FIXATION SYSTEM

    MDR report key: 226573 · Received June 4, 1999

    Report

    Report Number
    1030489-1999-00085
    Event Type
    Injury
    Date Received
    June 4, 1999
    Date of Event
    September 8, 1992
    Report Date
    May 7, 1999
    Manufacturer
    SOFAMOR DANEK EUROPE
    Product Code
    JDN
    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: 1991. POST OPERATIVE X-RAYS TAKEN IN 08/1992 REVEAL BROKEN SCREWS. REVISION SURGERY ON 09/08/1992 TO REPLACE BROKEN SCREWS. POST OPERATIVE X-RAYS REVEALED BROKEN SCREWS AND A NON-UNION. REVISION SURGERY ON 03/31/1994 TO REPLACE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention