BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD SPINAL SYSTEM

    MDR report key: 210893 · Received February 19, 1999

    Report

    Report Number
    1030489-1999-00022
    Event Type
    Injury
    Date Received
    February 19, 1999
    Date of Event
    April 8, 1996
    Report Date
    January 21, 1999
    Manufacturer
    SOFAMOR DANEK EUROPE
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON 01/19/1995. DUE TO PSEUDOARTHROSIS, REVISION SURGERY WAS PERFORMED ON 04/08/1996 TO REMOVE INSTRUMENTATION AND REPAIR PSEUDOARTHROSIS. MEDICAL RECORDS INDICATE THAT SCREWS WERE LOOSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention