BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 205303 · Received January 8, 1999

    Report

    Report Number
    1030489-1999-00003
    Event Type
    Injury
    Date Received
    January 8, 1999
    Date of Event
    February 1, 1996
    Report Date
    January 4, 1999
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    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 5/21/1993. PT WAS REPORTED TO HAVE DEVELOPED SYMPTOMATIC PSEUDARTHROSIS, LOW BACK PAIN AND RADICULAR LEG PAIN. DEVICE WAS EXPLANTED 2/1/96. SCREWS IN SACRUM WERE FOUND TO BE LOOSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention