BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 226568 · Received June 4, 1999

    Report

    Report Number
    1030489-1999-00077
    Event Type
    Injury
    Date Received
    June 4, 1999
    Date of Event
    October 10, 1995
    Report Date
    May 7, 1999
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    Product Code
    JDN
    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: 1994. POST OPERATIVE X-RAYS TAKEN IN 04/1995 REVEAL A BROKEN SCREW. EXPLANTED ON 10/10/1995 AT WHICH TIME A PSEUDOARTHROSIS WAS FOUND. A PIECE OF THE BROKEN SCREW COULD NOT BE REMOVED AND REMAINS IMBEDDED IN PATIENT'S BONE. PATIENT WAS RE-INSTRUMENTED WITH A DEVICE FROM ANOTHER MANUFACTURER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention