BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY SPINE

    MDR report key: 889419 · Received August 2, 2007

    Report

    Report Number
    MW5003252
    Event Type
    Injury
    Date Received
    August 2, 2007
    Report Date
    May 31, 2007
    Manufacturer
    DEPUY SPINE A JOHNSON AND JOHNSON COMPANY
    Product Code
    MJO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE MY DISK REPLACEMENT SURGERY IN 2005, I HAVE EXPERIENCED THE FOLLOWING SYMPTOMS. FELL TO THE GROUND WITH SHOOTING PAIN NUMEROUS TIMES - I CAN ONLY WAIT OUT THE PAIN - SOMETIMES HOURS, SOMETIMES DAYS. HAVE DIFFICULTIES STANDING UP FROM CERTAIN POSITIONS; MANY TIMES IT TAKES ME UP TO 5 MINUTES TO STAND UP COMPLETELY. AT TIMES I HAVE NUMBNESS AND TINGLING FROM MY BACK TO THE TOP OF MY LEGS AND SHOOTING PAIN FROM POINT OF DISK REPLACEMENT TO THE BACK OF MY HIPS - CANNOT SIT, STAND, OR DRIVE OVER 1 1/2 HRS WITHOUT HAVING THESE ISSUES. DIFFICULTY SLEEPING DUE TO BACK PAIN. I GET DIARRHEA ANYTIME MY BACK HURTS BADLY. I HAVE FELT GRINDING AND HEARD POPPING AT THE POINT OF DISK REPLACEMENT. LOSS OF MOBILITY - HAVE DIFFICULTY PUTTING ON SHOES. MY TREATING DOCTOR, DR FROM BILLINGS, MT HAS TOLD ME I WILL NEVER WORK AGAIN. AFTER REVIEWING THE MRIS AND X-RAYS, HE HAS DETERMINED THAT THE BOTTOM PLATE OF THE DISK REPLACEMENT IS TOO FAR FORWARD (10-11 MM) CAUSING A MAJOR CURVATURE IN MY SPINE AND THE FRONT OF THE BOTTOM PLATE HAS ATTACHED ITSELF TO TWO MAJOR ARTERIES DUE TO IT SLIDING SO FAR FORWARD. MY PHYSICIAN SAID HE CANNOT TAKE THIS OUT WITHOUT RUNNING A 70-80% CHANCE OF ME BLEEDING TO DEATH DURING SURGERY, TRYING TO REMOVE THE ARTERIES FROM THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY SPINE CHARIT'E ARTIFICIAL DISC MJO DEPUY SPINE A JOHNSON AND JOHNSON COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening| R| S