BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 224153 · Received May 19, 1999

    Report

    Report Number
    1030489-1999-00065
    Event Type
    Injury
    Date Received
    May 19, 1999
    Date of Event
    December 10, 1996
    Report Date
    April 20, 1999
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 06/22/1995. POST OPERATIVE X-RAYS OF A YEAR AND A HALF SHOW A BONE SCREW ON THE RIGHT IS LOOSE. REVISION SURGERY ON 12/10/1996 TO REMOVE HARDWARE AT WHICH TIME A PSEUDOARTHROSIS WAS FOUND.

    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 40 YR Required Intervention