Description of Event or Problem · 1
UNNECESSARY SURGERY "MEDTRONIC SOFAMER DANEK MYSTIQUE FIXATION DEVICE" AFTER AN AUTO ACCIDENT IN (B)(6) 2005, FUSION OF C6-C7 WAS FUSED USING THE PLASTIC "PEEK" CAGE DUE TO A SEVERE ALLERGY TO METALS, A FEW MINOR COMPLICATIONS AT THE BEGINNING WHICH RESOLVED. RECOVERY AHEAD OF SCHEDULE, AND WAS LOOKING FORWARD TO RETURNING TO WORK. I WAS MISLED BY MY SURGEON TO BELIEVE THAT THE ORIGINAL FUSION HAD FAILED. I HAD ANTERIOR BONE SPURS PRESENT AT THE TIME OF THE FIRST SURGERY. THIS WAS THE REASON USED TO SUPPORT HIS REASON FOR A "RE-DO" OF THAT LEVEL. THIS IS WHEN I WAS TOLD THAT "I" WAS A PERFECT CANDIDATE FOR THIS DEVICE, AND THAT IT WAS MADE FOR PEOPLE LIKE "ME" WITH ALLERGIES TO METAL. LONG STORY, MANY LIFE THREATENING COMPLICATIONS, DEVICE EXTRACTED 11 WEEKS LATER, ALTHOUGH THE BARIUM MARKERS STILL REMAIN¿ SIX OF THEM, AS WARNED BY MEDTRONIC -ALTHOUGH THEY WON'T GIVE ME THE INFORMATION "WHY" AN ALLERGY TO BARIUM IS A DETRIMENT TO YOUR LIFE- IF AN ALLERGY TO BARIUM EXISTS, IT IS NOT RECOMMENDED FOR USE. I READ MY SURGICAL REPORT, THE SCREWS KEPT BREAKING DURING SURGERY, IT WASN¿T ABORTED AT THAT TIME? THEY CONTINUED WITH THE SURGERY, DAY 3 THE DEVICE FAILED, HERE WE ARE 2010, JUST NOW FINDING OUT WITH "MY" OWN RESEARCH TO PROVE WHAT IS HAPPENING IS RELATED TO THE SURGERY AND THE BARIUM, BECAUSE NO-ONE ELSE WOULD HELP ME. WHEN ALLERGIC WHAT CAN HAPPEN, AND THAT IT IS A MATTER OF LIFE OR DEATH AND IN MY CASE... DEATH. OVER 290 CASES WHERE THIS DEVICE HAS INJURED PATIENTS, MOST REPORTED BY SURGEONS, NOT MINE. IT'S ONE BIG COVER UP FROM THE SURGEON TO THE MANUFACTURER. THE (B)(6). ADVISED ME TO GET TO THE NEAREST E.R. TO SEE A TOXICOLOGIST. IT'S NOT AS THOUGH THE MARKERS CAN JUST BE REMOVED. THEIR EMBEDDED IN MY BONE GRAFT. BARIUM CAUSES A WIDE RANGE OF HEALTH ISSUES WITH ONE BEING SWELLING OF THE BRAIN. I HAVE A CEREBRAL ANEURYSM, BUT DUE TO MY ALLERGY TO METAL I COULD NOT HAVE IT REPAIRED WITH THE TRADITIONAL METHOD. I HAVE A PLATINUM COIL, WHICH THE SUCCESS RATE OF THAT ALSO POSES SOME RISKS AS WELL. THIS COMPLICATES THE SURGERY TO REMOVE THE GRAFT WITH THE 6 MARKERS, AS IT WOULD BE CATASTROPHIC IF THIS SHOULD BE DAMAGED DURING THAT PROCEDURE. ALL IN ALL TOO MANY HEALTH ISSUES TO NAME, IMMINENT DEATH KNOCKING ON MY DOOR, SURGEON AND MEDTRONIC "NOT" TAKING RESPONSIBILITY FOR THE DEVICE OR THEIR ACTIONS, WHEN THE DEVICE BACKED OUT ON DAY 3, MY SURGEON HAD THE "SALES REP" COME IN TO READ THE SCAN AS THEY WERE "UNFAMILIAR' THIS ALSO IS A VIOLATION OF MY HIPPA RIGHTS, AND THEY HELD A CONFERENCE WITHOUT MY KNOWLEDGE AS MYSELF AS THE TEST SUBJECT AND THE DEVICE AS THE PRODUCT. "I" WAS THE FIRST FOR THIS TO BE USED ON IN OUR AREA, (B)(6). IF THEY HAD BEEN IN ATTENDANCE. TO DATE, MY HEALTH ISSUES CONTINUE. (B)(6) WAS A SPECIAL MONTH, MILD STROKE, HIGH BLOOD PRESSURE, INTOLERANCE TO HEAT, MS, TODAY OR THIS WEEK KIDNEY ISSUES. SEVERE EDEMA TO MY LEGS, FEET, AND HANDS. NEXT WEEK SURGERY, A CEREBRAL ANGIOGRAM TO MAKE SURE THE ANEURYSM IS STABLE ENOUGH FOR ANY TYPE OF SURGERY, LET ALONE MAJOR SURGERY TO REMOVE THE GRAFT AND 6 MARKERS. THIS TIME BECAUSE OF THE BARIUM DOES TO YOUR BONES, I NEED TO BE FUSED FROM C3 - T1. ALL BECAUSE NO ONE WANTED TO TAKE RESPONSIBILITY FOR A DEVICE WHICH INJURES, AND A SURGEON WHO WAS NOT TRAINED TO USE SUCH A DEVICE.