BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX

    MDR report key: 3519463 · Received December 5, 2013

    Report

    Report Number
    MW5033365
    Event Type
    Injury
    Date Received
    December 5, 2013
    Date of Event
    November 25, 2013
    Report Date
    December 4, 2013
    Manufacturer
    PARADIGM SPINE
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2013, I HAD 2 COFLEX (PARADIGMSPINE) DEVICES IMPLANTED INTO MY LOWER BACK. AFTER THE SURGERY I ENDURED EXTREME PAIN, AND HAD TO TAKE A LOT OF PAIN MEDICATION, I MISSED 3 MONTHS OF WORK. IN (B)(6), DURING A CHECKUP AND X-RAYS, I WAS TOLD THE DEVICES HAD HARDWARE FAILURE, HAD DISLODGED FROM MY VERTEBRAE AND NEEDED TO BE REMOVED, BECAUSE THERE WAS A CHANCE OF SERIOUS INJURY AND POSSIBLE PARALYSIS IN THE LEGS. AFTER SURGERY I WAS TOLD I HAD A FRACTURE IN MY SPINE, AND PART OF MY BONE HAD CHIPPED OFF DURING THE REMOVAL. I ASKED FOR THE COFLEX IMPLANTS BACK, SINCE I HAD PAID FOR THEM, AND CANNOT SEE ANYTHING VISUALLY WRONG WITH THEM. THE ORIGINAL BACK PAIN WAS DEGENERATIVE, AND NOT A RESULT OF ANY ACCIDENT, I SHOULD ALSO MENTION THAT ABOUT A YEAR AND A HALF AGO, I HAD 3 LEVELS OF MY NECK FUSED. I FEEL NO MORE SUBJECTS SHOULD BE PUT THROUGH THIS MUCH PAIN WITHOUT MORE RESEARCH BEING COMPLETED ON THE DEVICES IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631482 COFLEX COFLEX KWP PARADIGM SPINE UOI00012

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O