BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD SPINAL SYSTEM

    MDR report key: 210888 · Received February 19, 1999

    Report

    Report Number
    1030489-1999-00024
    Event Type
    Injury
    Date Received
    February 19, 1999
    Date of Event
    December 28, 1993
    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 12/08/1987. REVISION SURGERY WAS PERFORMED ON 12/28/1993 TO REMOVE INSTRUMENTATION. PATIENT HAD DEVELOPED A BURSITIS AT INSTRUMENTATION. PATIENT HAD SOLID FUSION. TWO BROKEN SCREWS AND A FRACTURED ROD WERE REMOVED.

    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 51 YR Required Intervention