BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO-DISC L

    MDR report key: 1338220 · Received March 5, 2009

    Report

    Report Number
    MW5010233
    Event Type
    Injury
    Date Received
    March 5, 2009
    Date of Event
    March 15, 2004
    Report Date
    March 5, 2009
    Manufacturer
    SPINE SYNTHESIS
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HELLO, I WAS INVOLVED IN THE CLINICAL TRIAL TO ASSESS THE BENEFIT FROM HAVING THE PRO-DISC IMPLANTED IN 2 LEVELS OF MY SPINE -VS. FUSION-. SINCE MY FAILED OPERATION IN 2004, THE FDA HAS APPROVED THIS DEVICE TO BE IMPLANTED AT ONE LEVEL OF PATIENTS' SPINES. AS I WROTE, I HAD 2 LEVELS DONE -14-5, 15-S1-. POST-SURGERY, I HAVE EXPERIENCED DIMINISHED PAIN IN SOME AREAS AND INCREASED PAIN IN OTHERS. I AM NOW UNABLE TO WORK OR DO MOST/MANY ACTIVITIES AS I WAS PRE-SURGERY AND AM IN CONSTANT PAIN IN MY L-BACK AND FOOT, LEGS, GROIN, TESTES ... WHY WASN'T THIS DEVICE APPROVED TO BE IMPLANTED AT MORE THAN ONE LEVEL? I CANNOT GET A STRAIGHT ANSWER FROM MY SURGEON. PERHAPS YOU CAN SHED SOME LIGHT ON THIS FOR ME. IT'S MY WHOLE LIFE BEING AFFECTED. I LOST MY JOB, WIFE AND MORE THAN I CAN EVER EXPLAIN. MANY FORMS OF POST-OP THERAPY, INCLUDING; PHYSICAL-THERAPY, WORK HARDENING. EPIDURAL STEROID INJECTIONS, OBLATION OF NERVES. DOSE OR AMOUNT: 2 LEVELS. ROUTE: OTHER. DIAGNOSIS OR REASON FOR USE: DEGENERATIVE DISC DISEASE. ANTERIOR TORN L4-5, L5-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-DISC L PRO-DISC L MJO SPINE SYNTHESIS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention