BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE, INC.

    MDR report key: 997208 · Received February 7, 2008

    Report

    Report Number
    MW5005399
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    December 20, 2006
    Report Date
    February 7, 2008
    Manufacturer
    NUVASIVE INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A NUVASIVE INC. COHERENT ARTIFICIAL DISC IMPLANT IN 2006, IMPLANTED IN MY SPINE AT 12-3 FOR A HERNIATED DISC REPLACEMENT. DURING MY BRIEF HOSPITAL STAY AND COMPLAINING TO HOSPITAL STAFF, NOTHING WAS TESTED TO SEE IF THE DEVICE FAILED. I WAS READMITTED TO HOSPITAL FOR EMERGENCY SURGERY IN EARLY 2007. THE DEVICE AGAIN MIGRATED AND DID PERMANENT NERVE AND MUSCLE DAMAGE AND I REQUIRED 5 ADDITIONAL CORRECTIVE SURGERIES INCLUDING A LIFE THREATENING REMOVAL OF THE IMPLANT FIVE MONTHS LATER. NOW PERMANENTLY DISABLED, NEED TO SELL MY HOME DUE TO NOT BEING ABLE TO WORK. I AM NOW BEING TOLD I WILL NEVER WORK AGAIN DUE TO THE MALFUNCTION OF THIS DEVICE AND THE PERMANENT DAMAGE; IT HAS OCCURRED BOTH PHYSICALLY AND MENTALLY. I HAVE BEEN ADVISED THAT I WILL NEVER BE ABLE TO WALK OR DO ANY NORMAL ACTIVITIES AND NOW HAVE A SPINAL CORD STIMULATOR IMPLANTED FOR THE PERMANENT AND DEBILATING PAIN I ENCOUNTER DAILY. HOW COULD YOUR AGENCY APPROVE SOMETHING THAT HAD CAUSED MUCH DISTRESS IN NUMEROUS PTS RECEIVING THESE ARTIFICIAL IMPLANTS THAT ARE REMAINING IN PLACE ONCE IMPLANTED? INCIDENTLY, MY IMPLANT MIGRATED ANTERIORY TOWARDS MY AORTA VALVE AND FRACTURED MY VERTEBRA WHICH MOVED POSTERIORLY. I WOULD LIKE A FORMAL REPLY FROM AN INDIVIDUAL FROM THE FDA IN REGARDS TO THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVASIVE, INC. COROENT SYSTEM MCV NUVASIVE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| O| R| S