66MM 3 LEVEL PLATE, 18MM VST SCREW, 16MM VST SCREW, 18MM VSD SCREW

Description of Event or Problem

IN (B)(6) 2018, I HAD A SPINAL FUSION SURGERY PERFORMED IN MY CERVICAL SPINE. THE HARDWARE (SCREWS & PLATE) THAT WAS USED WAS MANUFACTURED BY NEXXT SPINE. IMAGES TAKEN DURING MY FIRST FOLLOW-UP POST-SURGERY SHOWED EVERYTHING WAS CORRECT AND NO PROBLEMS WERE PRESENT. LIKEWISE, ALL DISCOMFORT WAS GONE AND MOST NUMBING/TINGLING WAS GONE AS WELL. SOME PROBLEMS AND DISCOMFORT BEGAN TO ARISE OVER THE PAST YEAR OR SO, AND I THEREFORE DECIDED TO SEE A NEUROSURGEON RECENTLY IN ORDER TO REQUEST AN MRI, CT AND X-RAY. ALL IMAGES AND ACCOMPANYING REPORTS HAVE REVEALED TWO MAJOR PROBLEMS. FIRST, BOTH TITANIUM SCREWS IN MY C6 VERTEBRAE ARE BROKEN IN HALF INSIDE THE BONE. SECOND, THE SAFETY MECHANISM DESIGNED TO PREVENT THE SCREWS FROM BACKING OUT HAS FAILED, RESULTING IN THE SCREW PROTRUDING OUTWARD BY 4 TO 5 MILLIMETERS. IF THIS WERE JUST ONE FAILURE IT COULD, MAYBE CHALKED UP TO A FLUKE, BUT THERE ARE THREE FAILURES OCCURRING HERE SIMULTANEOUSLY, AND I AM CONSEQUENTLY FACED WITH A VERY BAD SITUATION AND RISKY DECISIONS INVOLVING THE CERVICAL SPINE, NOT TO MENTION THE STRESS AND DISCOMFORT. FDA SAFETY REPORT ID# (B)(4).