Description of Event or Problem · 1
SPINAL KINETIC BASED IN (B)(6), DEVELOPED THE M6 ARTIFICIAL DISC REPLACEMENT PRODUCT AND WAS ADVERTISING IT ONLINE WITH THE PROMISE OF "MOTION FOR LIFE" (THEIR TAGLINE). THIS PRODUCT WAS NOT FDA APPROVED, BUT THEY WERE ADVERTISING ONLINE AND VIA DOCTORS GLOBALLY. I HAD SEVERE PROBLEMS WITHIN MY CERVICAL SPINE THAT REQUIRED A MULTIPLE LEVEL DISC REPLACEMENT AND FUSION. AT THE TIME, MY DR IN (B)(6) ENCOURAGED ME TO FIND A SOLUTION INTERNATIONALLY, IN ORDER TO HAVE ONE VS. MANY SURGERIES. I DISCOVERED THE M6 DISC AND THOUGHT IT WAS MY ANSWER, WITH THE PROMISE OF BEING ABLE TO RETURN TO ALL MY ACTIVITIES. IT SEEMED LIKE AN AMAZING OPTION, TO REPAIR MY DAMAGED NECK. THE ONLY OPTION FOR ME WAS TO TRAVEL TO (B)(6) TO REPLACE FOUR DISCS IN MY NECK IN BOTH 2009 AND 2010. THE PRODUCT IS MANUFACTURED IN THE US, BUT SENT FOR NON-FDA APPROVED SURGERY ALL OVER THE WORLD. THEY HAVE MANAGED TO CIRCUMVENT THE FDA. I PLACED MY TRUST IN SPINAL KINETICS AND MY DOCTORS. UNFORTUNATELY, I HAD YEARS OF PROBLEMS AND RE-OCCURRING PAIN. DUE TO WORSENING PAIN, I HAD A NEW MRI IN (B)(6) 2015, AT WHICH TIME I DISCOVERED THAT THE M6 DISCS WERE CAUSING OSTEOLYSIS, SEVERE SPINAL STENOSIS AND AUTO-FUSION. ONE OF THE DISCS REPLACEMENTS HAD LOOSENED IN MY SPINE, CAUSING 42% SPINAL CORD IMPINGEMENT. THIS WAS A VERY DANGEROUS SITUATION THAT REQUIRED MEDICAL ATTENTION QUICKLY. I HAD TO GO BACK (B)(6) FOR A FOURTH SURGERY, IN ORDER TO ENDURE A COMPLEX, DIFFICULT CERVICAL SPINE RECONSTRUCTION. ALL THE M6 DISCS WERE REMOVED, IN ORDER TO PREVENT FURTHER BREAKDOWN OF BONE, BONE GROWTH AND OTHER DANGERS. ONE LEVEL HAD AUTO-FUSED, WHICH DEFEATS THE PURPOSE OF A DISC REPLACEMENT. THE OTHER THREE WERE REPLACED WITH FDA APPROVED ARTIFICIAL DISCS. THE SURGERY WAS VERY PAINFUL AND REQUIRED TWO DAYS OF INTENSIVE CARE INTUBATION AND A LENGTHY RECOVERY. UNFORTUNATELY, I LEARNED THAT SPINAL KINETICS HAS ONLY CONDUCTED A ONE-LEVEL, ONE YEAR STUDY ON THEIR M6 DISCS. HOWEVER, THEY HAVE BEEN SELLING THIS PRODUCT GLOBALLY FOR MULTIPLE LEVEL DISC REPLACEMENT APPLICATION, FOR WHICH IT IS NOT VIABLE. MY CASE IS A PERFECT EXAMPLE OF WHY THIS PRODUCT IS INFERIOR AND EXTREMELY DANGEROUS. WITHIN 5-6 YRS, THESE PRODUCTS BREAK SPARK AND DISINTEGRATE WITHIN THE SPINE, CAUSING ALL TYPES OF DAMAGE AND RISKS. I HAD MY DOCTOR IN (B)(6) SAFELY AND COMPLETELY REMOVE TWO OF THE DISC REPLACEMENT PRODUCTS, IN ORDER TO PROVE HOW DEFECTIVE THEY ARE. I APPROACHED SPINAL KINETICS DIRECTLY ABOUT THE ISSUES AND THEY DENIED THAT THEIR PRODUCT WAS TO BLAME. THEY EVEN WENT ON TO SAY THAT THEIR PRODUCT IS SUPERIOR TO ALL OTHERS ON THE MARKET, WHEN I HAD PROOF IN BLACK AND WHITE AND IN PHOTOS THAT SOMETHING WENT SERIOUSLY WRONG. THEY HAD SEVERAL CONVERSATION WITH ME WITH ALL THEIR TIP LEVEL EXECUTIVES AND THEY CONTINUE TO IGNORE THE FACTS. I AM NOT THE ONLY VICTIM OF THE M6 DISC. I SUFFERED EXTENSIVELY FROM THE THREE SURGERIES I HAD, IN CONNECTION WITH THE M6 DISCS. SO THIS COMPANY NEEDS TO BE HELD ACCOUNTABLE FOR THEIR PRODUCT FAILURE. THEY ESPECIALLY SHOULD NOT BE ALLOWED TO SELL THEIR PRODUCTS INTERNATIONALLY, WHEN THEY HAVE NOT BEEN FDA APPROVED, AND WHEN THE PRODUCT IS ACTUALLY DANGEROUS WHEN USED ON MULTIPLE LEVELS OF THE SPINE. I HAD MY FIRST SURGERY ON (B)(6) 2009 - C4-5, C5-6, C6-7 DISC REPLACEMENTS. SECOND SURGERY WAS (B)(6) 2010. THIRD SURGERY WAS TO REMOVE FUSION SCREWS, WHICH ISN'T APPLICABLE. FOURTH SURGERY WAS ON (B)(6) 2015 TO REMOVE THE DEFECTIVE M6 DISCS, REPAIR THE DAMAGE AND REPLACE THE HARDWARE.