BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 224155 · Received May 19, 1999

    Report

    Report Number
    1030489-1999-00049
    Event Type
    Injury
    Date Received
    May 19, 1999
    Date of Event
    March 3, 1994
    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: 6/11/1990. PT DEVELOPED LOW BACK PAIN WHILE UNDERGOING PHYSICAL THERAPY. REVISION SURGERY ON 10/13/1992 AT WHICH TIME IT WAS NOTED THAT IMPLANTS WERE TIGHT DURING THE REMOVAL. NON-UNION REPAIRED AND HARDWARE REPLACED. THOSE DEVICES WERE EXPLANTED ON 2/3/1994 AND FUSION WAS OBSERVED.

    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 28 YR Required Intervention