BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 170168 · Received May 29, 1998

    Report

    Report Number
    1030489-1998-00039
    Event Type
    Injury
    Date Received
    May 29, 1998
    Date of Event
    February 21, 1994
    Report Date
    April 29, 1998
    Manufacturer
    SOFAMOR DANEK MFG
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH INSTRUMENTATION ON 3/22/1992. INSTRUMENTATION WAS EXPLANTED DUE TO PSEUDOARTHROSIS ON 2/21/1994 AND PT WAS RE-INSTRUMENTED. EXPLANTED INSTRUMENTATION WAS NOTED TO BE LOOSE AT THE S1 AND L4 BILATERALLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention