BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO DIC C

    MDR report key: 1263269 · Received December 3, 2008

    Report

    Report Number
    MW5009189
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    August 19, 2005
    Report Date
    December 3, 2008
    Manufacturer
    SYNTHES
    Product Code
    MJO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2005, I HAD THE PRO SPINCE CERVICAL DISK IMPLANT PUT INTO MY CERVICAL SPINE AT LEVELS C5-6. APPROX 18 MOS LATER, MY SPINE WAS STILL CAUSING ME PROBLEMS, BUT I ATTRIBUTED IT TO ONGOING ROTATOR CUFF TEARS. I HAD A MYELOGRAM DONE IN 2008 WHICH SHOWED SEVERE NEURAL FORAMINAL ENCROUCHMENT. AN EMG SHOWED SEVERE LEVEL 4 ATROPHY OF SHOULDER MUSCLES WHICH ARE PERMANENTLY DISABLED. I HAVE NERVE DAMAGE TO MY C6 NERVE. THE DISC DOES NOT MOVE AND THERE IS NO SAGITTAL MOVEMENT IN THE DISK. MY NEUROSURGEON TOLD ME THE DISC FAILED AS A RESULT. THE SURGERY WAS DONE IN OTHER COUNTRY, BUT THE MFR IS SYNTHES IN SWITZERLAND. IT IS IMPERATIVE THIS PROD BE REMOVED FROM THE MARKET. DURING THE CLINICAL TRIALS IN THE US, SEVERAL PHYSICIANS INVOLVED IN THE CLINICAL TRIALS HAD A FINANCIAL INTEREST IN THE OUTCOME OF THE TRIALS MAKING THE TRIALS INACCURATE. THE HYPE ON THIS DISC OVER OTHER DISCS WAS UNPARALELLED. TREMENDOUS AMOUNT OF MARKETING WAS DONE FOR THIS DISC AND HIGHLY PROMOTED BY SIGNIFICANT WELL KNOWN SURGEONS WHO HAD VESTED INTERESTS AND THESE WERE NOT DISCLOSED TO THE PTS. MY SURGEON IN THAILAND IMPLANTED MY DISC WRONG AND IS TOO FAR "VENTRAL". MY MUNICH GERMANY DR WANTS TO REMOVE THE DISK AND NOW I AM UNSURE IF HE WAS A CONTRIBUTOR TO THE PRO DISC C AND HAD A VESTED INTEREST. THE FDA KNOWS THAT DISK IS APPROVED FOR IMPLANTATION MUST REQUIRE THE DR TO DISCLOSE AND HAVE A SIGNED PT AUTHORIZATION STATING THE PT KNOWS ABOUT DISCLOSURE AND IS FULLY AWARE OF THE EFFECTS OF THAT DISCLOSURE 6 MOS PRIOR TO ANY IMPLANTATION, GIVING THE PT A CHANCE TO REVIEW AND UNDERSTAND THESE IMPLICATIONS. THIS DISC IS A FAILURE AND MUST BE REMOVED FROM THE MARKET. I HAVE A PERMANENT LIFE THREATENING INJURY AS A RESULT OF THIS DISC. THE INTL HOSPS MUST BE REQUIRED TO DIVULGE THEIR FINANCIAL INTEREST IN A PROD AND ANY AND ALL SOURCES OF CONTRIBUTION. ANOTHER COUNTRIES HOSP ARE RESPONSIBLE FOR PART OF THE FAILURE OF THE DISC AS IT WAS IMPLANTED TOO FAR VENTRAL AND HAS COMPROMISED MY LIFE AND LIVING. I AM HOMELESS BECAUSE I TOOK OUT A MORTGAGE ON MY HOME TO PAY FOR A SURGERY THAT FAILED. PLEASE REMOVE THIS DISC IMMEDIATELY. IT IS UNSAFE AND MANY LAWSUITS WILL COME AS THIS DISC IS IMPLANTED. STOP THIS BEFORE OTHERS ARE INJURED AND KILLED. PRO DISC C IS UNSAFE. SYHTHES HAS BEEN INFORMED OF MY DISC FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO DIC C ADR ARTIFICIAL DISK IMPLANT MJO SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R| S