BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 288520 · Received August 3, 2000

    Report

    Report Number
    1030489-2000-00186
    Event Type
    Injury
    Date Received
    August 3, 2000
    Date of Event
    May 2, 1994
    Report Date
    July 12, 2000
    Manufacturer
    MEDTRONIC 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. REVISION SURGERY IN 1994 DUE TO PSEUDOARTHROSIS AND A BROKEN SCREW. DEVICE REPLACED. X-RAYS TAKEN ON 05/21/1996 SHOW A BROKEN SCREW. REPLACED DEVICE HAS NOT BEEN REPORTED TO HAVE BEEN EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention