BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 226430 · Received June 4, 1999

    Report

    Report Number
    1030489-1999-00074
    Event Type
    Injury
    Date Received
    June 4, 1999
    Date of Event
    June 1, 1995
    Report Date
    May 7, 1999
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 1994. PT COMPLAINED OF PAIN. EXPLANTED ON 06/01/1995 AT WHICH TIME A PSEUDOARTHROSIS WAS FOUND. PT WAS RE-INSTRUMENTED. PT CONTINUED TO COMPLAIN OF PAIN. REVISION SURGERY ON 02/15/1999 TO REMOVE DEVICE AT WHICH TIME A PSEUDOARTHROSIS AND SOME "MOTION" IN THE DEVICE WAS FOUND.

    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 22 YR Required Intervention