BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW

    MDR report key: 17022 · Received September 15, 1994

    Report

    Report Number
    MW4000533
    Event Type
    Malfunction
    Date Received
    September 15, 1994
    Report Date
    September 15, 1994
    Manufacturer
    DANEK MEDICAL, INC.
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SIX SCREWS USED IN LOWER BACK FROM L3-L5, BOTH SIDES. RPTR IS IN CONSTANT PAIN AND DOESN'T KNOW IF IT IS RELATED TO SCREWS. OPERATION DID NOT RELIEVE PAIN. HE HAS BEEN IN PAIN MANAGEMENT THERAPY FOR THE PAST 5 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDICLE SCREW Implant MCV DANEK MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *