BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 258334 · Received January 5, 2000

    Report

    Report Number
    1030489-2000-00005
    Event Type
    Injury
    Date Received
    January 5, 2000
    Date of Event
    July 8, 1994
    Report Date
    December 7, 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

    IMPLANT DATE: 1993. PT COMPLAINS OF PAIN. X-RAYS TAKEN ON 02/16/1994 INDICATE A FRACTURED SCREW. REVISION SURGERY IN 1994 TO REPLACE DEVICE AND REPAIR FUSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention