BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 224178 · Received May 19, 1999

    Report

    Report Number
    1030489-1999-00054
    Event Type
    Injury
    Date Received
    May 19, 1999
    Date of Event
    April 8, 1991
    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: 12/14/1990. POST-OPERATIVE X-RAYS REVEALED ROD AND TWO UPPER HOOKS LOOSE. REVISION SURGERY ON 4/8/1991 FOR PARTIAL REMOVAL OF LOOSE ROD. SUBSEQUENTLY, PT EXPERIENCED PAIN AND OTHER SYMPTOMS. REMAINING DEVICES WERE EXPLANTED ON 12/10/1991. AT THE TIME OF EXPLANT FUSION WAS FOUND TO BE SOLID.

    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 21 YR Required Intervention