BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 291342 · Received August 16, 2000

    Report

    Report Number
    1030489-2000-00255
    Event Type
    Malfunction
    Date Received
    August 16, 2000
    Date of Event
    December 6, 1994
    Report Date
    July 18, 2000
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MANUFACTURING
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 1993. PT COMPLAINS OF PAIN AND OF FOOT DROP. X-RAYS TAKEN ON 12/06/1994 INDICATE A PSEUDOARTHROSIS AND A BROKEN SCREW. NOT 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 36 YR Required Intervention