BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDX LOWER LUMBAR EXTENSION MACHINE

    MDR report key: 251172 · Received November 23, 1999

    Report

    Report Number
    MW1017628
    Event Type
    Injury
    Date Received
    November 23, 1999
    Date of Event
    June 29, 1998
    Report Date
    November 18, 1999
    Manufacturer
    MEDX 96, INC.
    Product Code
    ION
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    RPTR WRITES: "IN THE SPRING OF 1998, I WAS HAVING SOME MINOR DIFFICULTY WITH MY MIDDLE BACK AND SOUGHT MEDICAL ATTENTION FOR IT. THE PROBLEM WAS QUICKLY RELIEVED BY A PHYSICIAN WITH AN OFFICE VISIT THAT BASICALLY INVOLVED A BEAR HUG TYPE TREATMENT FOLLOWED UP BY A FEW PHYSICAL THERAPY SESSIONS TO HELP STRENGTHEN AND MAINTAIN MY BACK POSTURE. IT WAS THEN SUGGESTED THAT I BECOME INVOLVED IN MORE ACTIVE PHYSICAL THERAPY WITH THE USE OF MEDX TYPE PHYSICAL THERAPY EQUIPMENT TO STRENGTHEN MY UPPER BACK/NECK AND LOWER BACK WHEREBY THE MIDDLE OF MY BACK WOULD FURTHER BENEFIT AS A RESULT. SHORTLY THEREAFTER I STARTED A PHYSICAL THERAPY ROUTINE OF ALTERNATING THE USE OF A CERVICAL MEDX AND A LUMBAR MEDX MACHINE. DESPITE INFORMING MY PHYSICAL THERAPIST ASSISTANT THAT THE LOWER BACK SUPPORT OF THE MEDX LUMBAR-EXTENSION MACHINE DID NOT FEEL VERY COMFORTABLE WHILE PERFORMING THE THERAPY ROUTINE, THE PROGRAM CONTINUED. SHORTLY AFTER THE FOURTH USE OF THE MEDX LOWER LUMBAR EXTENSION MACHINE, MY LOWER BACK, HIPS, PELVIS, AND LEFT LEG BECAME EXTREMELY PAINFUL AND DYSFUNCTIONAL. IT WAS VERY DIFFICULT AND UNCOMFORTABLE TO SIT, STAND, AND WALK IN A NORMAL FASHION. MY LOWER BACK AND BODY WERE IN VARIOUS STAGES OF TRAUMA, SPASM, AND PAIN. THESE SYMPTOMS AND EFFECTS MADE IT DIFFICULT FOR ME TO PERFORM MY DUTIES AND PROCEDURES AS A DENTIST. THIS CONDITION ALSO CARRIED OVER AND INTERFERED WITH MY LIFESTYLE OUTSIDE THE OFFICE AND AT HOME. TWO MOS LATER AT MY INSISTENCE, AND AFTER VARIOUS OTHER HANDS ON TYPE PHYSICAL THERAPY, MEDICATION, AND EXERCISES, I INSISTED ON HAVING X-RAYS AND MRI EVAL OF MY LOWER BACK. THE RESULTS REVEALED THE MAJOR CAUSE OF MY PROBLEMS AS BEING RELATED TO A 4-5 MM HERNIATION AT L5-S1. THIS MEDX LOWER LUMBAR EXTENSION MACHINE AND ITS OPERATORS LITERALLY TORE MY LOWER BACK APART AND CHANGED MY LIFE FOREVER. A SURGERY FOLLOWED IN 12/98. A RELAPSE OCCURRED IN 2/99. ADD'L PHYSICAL THERAPY WAS INITIATED SHORTLY THEREAFTER. FURTHER MEDICAL CONSULTATIONS IN MARCH, APRIL, AND JULY OF 1999, AND MRI STUDIES AND X-RAYS SUGGESTED ADD'L SURGERY WOULD BE NEEDED. A QUALITY OF LIFE DECISION FORCED ME TO LEAVE DENTISTRY AND PURSUE MY HEALTH CONCERNS MORE SO. MY DENTAL CAREER ENDED AT THE END OF JULY 1999, AS IT BECAME UNBEARABLE TO COMFORTABLY SIT, CONCENTRATE, AND PERFORM DENTISTRY IN THE STYLE AND MANNER THAT I WAS TAUGHT AND ACCUSTOMED TO, OR IN ANY OTHER MANNER I ATTEMPTED. I AM CURRENTLY RECEIVING VARIOUS PHYSICAL THERAPY TECHNIQUES AND PAIN MANAGEMENT REGIMENS TO HELP WITH THE DISTRACTING PAIN AND THOSE SIDE EFFECTS AS WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDX LOWER LUMBAR EXTENSION MACHINE ISO-KENETIC PHYSICAL THERAPY MACHINE ION MEDX 96, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| S CERVICAL 6/17, 6/22, 6/26, 7/1, 7/3, 7/6, 7/8,| LUMBAR 6/15, 6/19, 6/24/1998,| 7/10, 7/13, 7/15.