BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 139413 · Received December 19, 1997

    Report

    Report Number
    1030489-1997-00186
    Event Type
    Injury
    Date Received
    December 19, 1997
    Date of Event
    March 6, 1994
    Report Date
    November 20, 1997
    Manufacturer
    SOFAMOR DANEK MEDICAL, INC.
    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 UNDERWENT INSTRUMENTATION SURGERY ON 5/27/92. INSTRUMENTATION WAS PLACED AT L4-S1 BILATERALLY. HE DID RELATIVELY WELL UNTIL 3/94, AT WHICH TIME HE SUDDENLY DEVELOPED SEVERE STABBING PAIN IN HIS LOWER BACK. X-RAYS SHOWED THE RIGHT ROD HAD MIGRATED, AND THERE WAS NO EVIDENCE OF SIGNIFICANT LATERAL FUSION MASS. EXPLANTATION SURGERY WAS PERFORMED ON 3/6/94. THE EXPLANTATION OPERATIVE REPORT INDICATES THAT THE RIGHT ROD HAD MIGRATED, AND THE LEFT ROD HAD APPARENTLY SLID BACKWARD. ALL 6 SCREWS WERE NOTED TO BE LOOSE BUT HAD TO BE UNSCREWED. ALL 6 SCREWS WERE REMOVED INTACT. THERE ALSO WAS REPAIR OF A DURAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM Implant SPINAL FIXATION DEVICE KWP SOFAMOR DANEK MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention