BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 161884 · Received April 9, 1998

    Report

    Report Number
    1030489-1998-00017
    Event Type
    Injury
    Date Received
    April 9, 1998
    Date of Event
    June 16, 1993
    Report Date
    March 10, 1998
    Manufacturer
    SOFAMOR DANEK MFG
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS IMPLANTED ON 12/13/90. REVISION SURGERY WAS PERFORMED ON 6/16/1993. MEDICAL RECORDS INDICATE PSEUDOARTHROSIS AT TIME OF EXPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention