BEUDAMED
    FDA Adverse Event Summary report: N

    DANEK

    MDR report key: 249851 · Received November 16, 1999

    Report

    Report Number
    MW1017561
    Date Received
    November 16, 1999
    Date of Event
    October 1, 1992
    Report Date
    November 16, 1999
    Manufacturer
    DANEK MEDICAL, INC.
    Product Code
    MCV
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SINCE THE SCREWS WERE IMPLANTED, USER'S QUALITY OF LIFE HAS DECREASED DUE TO NEUROLOGICAL IMPINGEMENT. USER NOW EXPERIENCES HIGH LEVEL OF PAIN FOR WHICH HE NEEDS REGULAR TREATMENT. USER BELIEVES THE SCREWS WERE USED INCORRECTLY FOR HIM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR