BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D- TRAX POSTERIOR CERVICAL FUSION DEVICES

    MDR report key: 8336851 · Received February 12, 2019

    Report

    Report Number
    MW5084002
    Event Type
    Injury
    Date Received
    February 12, 2019
    Date of Event
    February 6, 2017
    Report Date
    February 12, 2019
    Manufacturer
    PROVIDENCE MEDICAL TECH. INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A (B)(6) MALE. I FELL 4 YEARS AGO AND FRACTURED MY L-2 VERTEBRAE CAUSING BULGING DISCS AND PINCHED NERVES IN MY LUMBAR AREA. IN (B)(6) 2017, A NEUROSURGEON TOLD ME MY LOWER BACK PAIN WAS CAUSED BY 2 PROTRUDING DISCS IN MY C-SPINE AND NEEDED TO COME OUT. ON (B)(6) 2017, HE REMOVED DISCS AND FUSED MY C-SPINE WITH 4 PROVIDENCE MEDICAL TECHNOLOGY D-TRAX FUSION CAGES. THESE DEVICES HAVE AN OVER 80% FAILURE RATE AND COME OUT AND MIGRATE AS MINE DID, CAUSING MY C-SPINE TO FRACTURE IN 2 PLACES. BEFORE SURGERY, I HAD NO NECK PAIN. NOW I SUFFER DAILY, NEED A MAJOR ANTERIOR SURGERY TO FIX MY MIS-ALIGNED BROKEN NECK, YET NO SURGEON WILL FOLLOW BEHIND ANOTHER¿S MISTAKE. I HAVE SEVERE BLADDER INCONTINENCE, PASS OUT REGULARLY AND AM PARTIALLY PARALYZED ON R-SIDE OF MY BODY. THESE D-TRAX CAGES COME WITH THEIR OWN WARNINGS, RISKS AND COMPLICATIONS. THE DR WAS REQUIRED TO TELL ME, BUT DIDN¿T. I HAVE FOUND OTHER PEOPLE WHO HAD THEM PUT IN THEIR NECK AND HAVE DAMAGE TODAY. SOMEONE NEEDS TO TAKE THEM OFF THE MARKET. PROVIDENCE MEDICAL TECHNOLOGY, C.E.O. (B)(6). NOTE: THEY ARE ONLY TO BE USED FOR DEGENERATIVE JOINT DISEASE. WHICH I DO NOT HAVE. NUMEROUS OTHER NEUROSURGEONS WHO WILL NOT USE THEM. ARTICLES ONLINE, (B)(6) VIDEOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123233 D- TRAX POSTERIOR CERVICAL FUSION DEVICES ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH PROVIDENCE MEDICAL TECH. INC. 21 CFR 801.15 (C)(1)(I)9F) IFU DOCUMENT # LBL-PMT-011

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| O| R| S