BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE MORPHOGENIC PROTEIN USED IN CERVIC-NECK

    MDR report key: 902149 · Received August 21, 2007

    Report

    Report Number
    MW5003491
    Event Type
    Injury
    Date Received
    August 21, 2007
    Date of Event
    January 4, 2004
    Report Date
    August 21, 2007
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON THE ABOVE DATE I HAD NECK SURGERY. I WAS TOLD BY MY DOCTOR THAT THE SUBSTANCE THAT HE WOULD BE USING TO REPLACE THE DISC MATERIAL WAS NEW ON THE MARKET AND IT WAS THE FIRST TIME HE WOULD BE USING IT. I HAVE EXPERIENCED HEALTH PROBLEMS SINCE THE DAY I CAME HOME. AT FIRST IT WAS SEVERE SWELLING THAT LASTED FOR ALMOST SIX MONTHS BEFORE I FELT BETTER, IT IS STILL SWOLLEN. I HAVE LOST A LOT OF WEIGHT. EATING IS PAINFUL AND IT IS DIFFICULT TO SWALLOW, IN FACT IF I TURN MY HEAD EVEN SLIGHTLY WHILE CHEWING AND SWALLOWING, I WILL CHOKE. MY VOICE HAD BECOME VERY STRAINED AND IT IS PAINFUL TO TALK. I HAVE PROBLEMS GURGLING WHILE SLEEPING. I HAVE BEGUN TO LOSE THE FEELINGS IN BOTH MY HANDS, IN FACT, WHEN I GO TO OPEN A DOOR KNOB, THE OTHER HAND WILL MIMIC THE MOVEMENT. THE PROCEDURE USED WAS BONE MORPHOGENIC PROTEIN WITH A TITANIUM PLATE. PLEASE HELP ME!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE MORPHOGENIC PROTEIN USED IN CERVIC-NECK NEK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Life Threatening| R