BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX CLAMP

    MDR report key: 6144328 · Received December 1, 2016

    Report

    Report Number
    MW5066481
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    April 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    PARADIGM SPINE, LLC.
    Product Code
    GDJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD COFLEX CLAMP INSTALLED ON L2 IN (B)(6) 2016. MY PAIN IS BETTER BUT I FEEL A CLICKING IN MY BACK AND IT'S NOT ISOLATED TO ANY ONE MOVEMENT, AND IT CAUSES ME PAIN, SOMETIMES STOPS ME IN MY TRACKS, IT EVEN HURTS WHEN I'M TURNING OVER IN BED. I WENT TO MY SURGEON IN (B)(6) AND TOLD HIM ABOUT IT, AND HE SENT ME TO PHYSICAL THERAPY AND PHYSICAL THERAPIST DOCTOR TOLD ME THEY COULDN'T DO ANYTHING FOR ME. I WENT BACK TO THE SURGEON AGAIN AND HE AGAIN REFERRED ME TO GO BACK TO PHYSICAL THERAPY AND SAID HE DISAGREES WITH THE PHYSICAL THERAPIST'S DIAGNOSIS. I ALSO HAVE A LARGE AMOUNT OF GAS LOCATED IN AN AREA OF WHERE THE SURGERY TOOK PLACE, AND I WENT TO SEE A GASTROLOGIST AND HE SAID IT WAS NORMAL, SO I THOUGHT THE GAS WAS CAUSING MY PAIN AND THAT WAS WHAT WAS MOVING AROUND IN ME, BUT APPARENTLY THAT'S NOT WHAT IT IS SO I'M STILL WONDERING WHAT'S GOING ON. I WANT TO KNOW IF THERE'S ANY OTHER PEOPLE THAT ARE REPORTING THIS OUT THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790873 COFLEX CLAMP COFLEX CLAMP GDJ PARADIGM SPINE, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other LYRICA