BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY CHARITE DISC

    MDR report key: 1300325 · Received January 28, 2009

    Report

    Report Number
    MW5009777
    Event Type
    Injury
    Date Received
    January 28, 2009
    Date of Event
    September 12, 2005
    Report Date
    January 28, 2009
    Manufacturer
    JOHNSON & JOHNSON DEPUY
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD A CHARITE ARTIFICIAL DISC DONE IN 2005. WAS DIAGNOSED WITH L5S1 & L4S1 RUPTURED DISCS. DOCTOR HAD ME WAIT TWO YEARS FOR THIS DEVICE, HE SAID FUSION WOULD JUST FAIL AT NEXT LEVEL, WAIT FOR CHARITE DISC HE SAID. THIS IS MY SECOND REPORT OF THIS DISC. JUST TO LET YOU KNOW THIS CHARITE DISC HAS DESTROYED MY BODY & MY HEALTH IN GENERAL. I HAVE BEEN DISABLED SINCE THE SURGERY THE SAME MONTH. MY LIFE IS FILLED WITH HEAVY PAIN DISABILITIES. LOST ABILITY TO VOID. NOW MUST CATHETERIZE MYSELF FOUR TIMES A DAY OR GET BLADDER INFECTIONS. HEAVY PAIN LEVEL 8 TO 9 THROUGHOUT THE DAY & NIGHT. STILL ON PAIN MEDICATIONS & MORE. WEAKNESS IN LEGS, PAIN NUMBNESS IN LEGS. CAN ONLY STAND FOR SEVERAL HOURS PER DAY SOMETIMES. CONSTANT ABDOMINAL GROIN, BLADDER PAIN, BACK PAIN, DIGESTIVE TROUBLES, SEXUAL DYSFUNCTION. NOW ALL DOCTORS ARE AFRAID TO HELP ME. LOST JOB, HOME, EVERYTHING AT 42. DOCTORS SAY I SHOULD HAVE THIS CHARITE DISC REMOVED, "BUT NO ONE WILL YET" BECAUSE THERE'S A GOOD CHANCE IT CANNOT BE REMOVED WITHOUT BLEEDING TO DEATH, OHH GREAT THANKS FOR NOT TELLING ME THAT WHEN I GOT IT IN THE MIDDLE OF MY BODY. IF THE DISC WEARS OUT OR BREAKS THERE'S A GOOD CHANCE I'M A DEAD MAN, CAUSE YOU CAN'T REMOVE IT WITHOUT TEARING ARTERIES & BLEEDING TO DEATH. THANKS CHARITE & FDA FOR LETTING ME KNOW THAT BEFORE HAND. IF I JUST HAD FUSION, I WOULD PROBABLY STILL BE WORKING. NOW I'M ON DISABILITY FOREVER. AND SINCE THE FDA APPROVED THE DEVICE, I HAVE NO LEGAL RECOURSE AGAINST THE MANUFACTURER OF THE DEVICE, THANKS FOR LOOKING OUT FOR US. OHH WELL JUST ANOTHER CASUALTY. DOSE: L5S1. DATES OF USE: 2005 - 2009. DIAGNOSIS: RUPTURED L5S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY CHARITE DISC CHARITE ARTIFICIAL DISC MJO JOHNSON & JOHNSON DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| R