BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINEMED TABLE - FDA 510(K) K051013

    MDR report key: 882038 · Received July 16, 2007

    Report

    Report Number
    MW5003064
    Event Type
    Other
    Date Received
    July 16, 2007
    Report Date
    July 15, 2007
    Manufacturer
    CERT HEALTH SCIENCES, LLC
    Product Code
    ITH
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    I AM A CHIROPRACTOR AND PURCHASED A SPINEMED TABLE IN 2006. THIS TABLE IS MARKETED TO BE AN ALTERNATIVE TO HAVING BACK SURGERY FOR THOSE INDIVIDUALS SUFFERING FROM HERNIATED DISCS, SPINAL STENOSIS, FACET SYNDROME, AND OTHER DEGENERATIVE SPINAL CONDITIONS. AFTER HAVING APPROX 15 PEOPLE ON THE TABLE AND GETTING A MODERATELY SUCCESSFUL RESPONSE FROM ONLY ONE PT, I WAS CONCERNED AND CALLED THE CO TO ASK IF THEY WOULD SEND A TECH TO MY OFFICE TO DETERMINE IF I WAS DOING SOMETHING WRONG OR IF THE TABLE WAS DEFECTIVE. THE CO'S SOLUTION WAS TO HAVE ME GO TO ANOTHER INDIVIDUAL'S OFFICE TO WATCH THEM SET UP A PT AND DO THE PROCEDURE. I FIND THIS SOLUTION TO THE PROBLEM DISTURBING AND USELESS. I HAVE SINCE SPOKEN WITH OTHER SPINEMED TABLE OWNERS AND HAVE FOUND THAT MY EXPERIENCE WITH THE TABLE IS NOT UNCOMMON. MORE OFTEN THAN NOT MOST PRACTITIONERS THAT I SPOKE TO ARE NOT SATISFIED WITH THE PT RESPONSE TO BEING ON THE TABLE. VERY FEW PEOPLE ARE GETTING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINEMED TABLE - FDA 510(K) K051013 ITH CERT HEALTH SCIENCES, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 YR