BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 224154 · Received May 19, 1999

    Report

    Report Number
    1030489-1999-00061
    Event Type
    Injury
    Date Received
    May 19, 1999
    Date of Event
    June 29, 1993
    Report Date
    April 20, 1999
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 01/27/1993. PATIENT COMPLAINED OF PAIN. REVISION SURGERY ON 06/29/1993 TO EXTEND ROD TO L3. DURING THE RECOVERY PERIOD, PATIENT RE-INJURED BACK ON A FALL. REVISION SURGERY AGAIN ON 01/04/1994 TO EXTEND THE CONSTRUCT UP ONE LEVEL. AT THIS TIME IT WAS FOUND THAT THE BONE SCREW AT L3 WAS LOOSE. DURING RECOVERY PERIOD, PATIENT COMPLAINED OF PAIN AND AGAIN RE-INJURED BACK IN ANOTHER FALL. REVISION SURGERY ON 08/22/1995 TO EXTEND THE LEVEL OF THE CONSTRUCT UP ONE LEVEL. AT THIS TIME IT WAS NOTED THAT THE EXISTING HARDWARE WAS ALL FIXED. SURGEON REPLACED PART OF THE HARDWARE. AT THE TIME OF THIS REPORT, THE IMPLANTS HAVE NOT BEEN REPORTED TO HAVE BEEN EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention