Description of Event or Problem · 0
IN 2003 (B)(6) NOW C.E.O. & DR. (B)(6) NEURO SURG. DEVELOPED THE DTRAX CERVICAL SPINAL FUSION DEVICES. 2003-2006 THE TRIALS BEGAN ON REAL PATIENTS IN EUROPE WITHOUT ANY REGULATORY OVERSIGHT. THE COMPANY, (PROVIDENCE MEDICAL TECHNOLOGY) WAS CREATED, IN PLEASANTON CALIFORNIA. OTHER SPINAL FUSION PRODUCTS WERE PRODUCED. ACCORDING TO TRIALS DATA IN (B)(6) 2024, 40 % OF PATIENTS NEEDED 2ND AND 3RD REVISIONS FROM FAILURE, SOME WITH PERMANENT PARALYSIS. ON (B)(6) 2017, DR. (B)(6) AT (B)(6) HOSPITAL, (B)(6) USED THE DTRAX DEVICES TO FUSE MY NECK. THE DTRAX DEVICES WERE "NOT" CLEARED FOR USE IN THE U.S. BY THE FDA UNTIL MAY 22, 2018. 15 MONTHS AFTER PROVIDENCE RECEIVED IT'S FDA 510K APPROVAL. DR. (B)(6) HAD BEEN RECEIVING INCREMENTS OF PAYMENTS LISTED AS "(B)(6)" FROM PROVIDENCE. FOR 8 YEARS I HAVE SUFFERED WITH HORRIFIC NECK PAIN & HEADACHES 24/7. THE DEVICES MIGRATED CAUSING NERVE DAMAGE, I AM IN A WHEELCHAIR, LEFT SIDE PARALYSIS, INCONTINENCE. AND THERE ARE OTHERS. AFTER I FILED LEGAL ACTION THE DTRAX PRODUCT WAS REMOVED FROM IT'S WEB SITE AND SALES IN THE U.S., PARTNERED WITH STOECKLI MEDICAL IN SWITZERLAND, AND RENAMED THE SAME DEVICE CAVUS AND CORUS. MY LIFE IS RUINED. PROVIDENCE MEDICAL TECHNOLOGY HAS NEVER BEEN HELD ACCOUNTABLE FOR THOSE THE DTRAX SYSTEM HAS CAUSED CATASTROPHIC HARM TO. "WHY" WAS A PHYSICIAN USING DEVICES DURING A CLINICAL TRIAL, WITH NO FDA CLEARANCE? THE FDA FAILED TO MONITOR THIS COMPANY AS THESE DRUG AND DEVICE COMPANIE'S MISUSE THE SYSTEM ALL IN THE NAME OF BEING AHEAD OF THEIR COMPETITORS FOR MILLIONS OF DOLLARS. WHERE DOES THAT LEAVE ME. THANK YOU. (B)(6).