BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD SPINAL FIXATION SYSTEM

    MDR report key: 239066 · Received September 3, 1999

    Report

    Report Number
    1030489-1999-00141
    Event Type
    Injury
    Date Received
    September 3, 1999
    Date of Event
    December 15, 1992
    Report Date
    August 8, 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

    IMPLANT DATE: 1987. POST OPERATIVE X-RAYS REVEAL A PSEUDOARTHROSIS AND "LOOSE" IMPLANTS. REVISION SURGERY ON 12/15/1992 TO REPLACE IMPLANTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention