Description of Event or Problem · 1
IN 2007, I RECEIVED A REVISION OF POSTERIOR SPINAL FUSION C5-6 WITH BILATERAL LATERAL MASS SCREW FIXATION VIA THE VERTEX MAX SYSTEM WITH BONE MORPHOGENIC PROTEIN-2-INFUSE IN ADDITION TO MASTERGRAFT SURGERY. DR. EXPLAINED TO ME AND MY FAMILY THAT THE SOLUTION HE WAS GOING TO BE USING IN MY NECK WAS NOT APPROVED FOR USE IN THE NECK, BUT HE DIDN'T SEE WHY IT WOULDN'T WORK IN MY CASE. THE SURGERY WAS SUCCESSFUL AND IMMEDIATELY AFTER THE PAIN MEDICINES BEGAN TO WEAR OFF, I BEGAN COMPLAINING OF EXTREME BURNING SENSATION THAT BEGINS IN MY NECK AND RUNS DOWN MY SPINE. DURING RECOVERY THE BURNING WAS SO SEVERE THAT THE RECOVERY NURSES HAD MY NECK PACKED WITH ICE PACKS, I WAS BROUGHT TO MY HOSPITAL ROOM WITH THE ICE PACKS STILL ENCOMPASSING MY NECK. ON MY FOLLOW UP EXAMS, I CONTINUED TO COMPLAIN OF THIS ONGOING PAIN, AT ONE POINT DR. SAID IT MAYBE THE "BUMP" SOLUTION, BUT THAT IT SHOULD SUBSIDE. AS I CONTINUED TO SEE THE DR., AND THE PAIN CONTINUED. HE REFERRED ME TO A PAIN CLINIC THAT HAS NOT BEEN ABLE TO ASSIST ME IN STOPPING THE BURNING. I HAVE SINCE DONE RESEARCH ON THE INFUSE SOLUTION AND FOUND THAT IN FACT IT WAS NOT APPROVED FOR THE NECK AND THAT PATIENTS HAVE HAD NUMEROUS SIDE EFFECTS FROM THE USE OF IT IN THE NECK. I HAVE ALSO FOUND IN MY RESEARCH THAT THE PRODUCT IS MADE BY MEDTRONICS, AND THAT THE FACILITY IS CURRENTLY BEING SUED BY THE FDA FOR USE OF MEDTRONICS PRODUCTS THAT HAVE PROVIDED "KICK BACKS" TO NUMEROUS DOCTORS AT THE FACILITY. I CONTINUE TO HAVE BACK BURNING. I AM CURRENTLY USING PAIN MEDICATIONS, TENS UNIT AND SEEKING NON-TRADITIONAL TREATMENTS TO EASE THE DISCOMFORT. NONE OF THESE HAVE HELPED TO STOP THE BURNING PAIN. DATES OF USE: 2007 - 2008, OPERATIVE. DIAGNOSIS OR REASON FOR USE: SPINAL FUSION - "REDO".