Description of Event or Problem · 1
MY NAME IS (B)(6). I HAVE TWO SPINAL KINETICS M6 ARTIFICIAL DISCS IMPLANTED IN MY CERVICAL SPINE. I WANT TO REPORT THAT ONE OR BOTH HAVE BROKEN. I AM AWARE THAT THERE ARE CLINICAL TRIALS GOING ON IN THE U.S. AT THIS TIME, I AM NOT A PARTICIPANT IN ANY OF THOSE TRIALS. MY IMPLANTS WERE DONE AT (B)(6) HOSPITAL, IN (B)(6), IN (B)(6) OF 2007. I HAVE TWO M6 ARTIFICIAL DISCS, ((B)(4).) IMPLANTED AT C 4/5 AND C 5/6. I HAVE BEEN HAVING L ARM AND SHOULDER PAIN ALONG WITH NUMBNESS AND TINGLING IN MY L HAND, FOR OVER 18 MONTHS. IT WAS THOUGHT THAT BONE SPURS NEAR THE ARTIFICIAL DISCS WERE THE PROBLEM AND SO I HAD SCHEDULED SURGERY TO REMOVE THE BONE SPURS AT (B)(6) HOSPITAL, IN (B)(6), BY DR. (B)(6). WHEN HE GOT INTO MY NECK HE FOUND A PIECE OF METAL DEBRIS LOOSE IN THAT AREA. IT IS A PIECE OF THE M6 ARTIFICIAL DISC AT C 5/6. HE CLOSED THE INCISION AFTER REMOVING THE PIECE OF THE M6. I HAD A CT SCAN DONE AFTER THAT WHICH SHOWS THE M6 AT C 5/6 IS BROKEN WITH ANOTHER PIECE OF DEBRIS STILL IN THAT AREA. IT ALSO SHOWS THAT THE M6 AT C 4/5 IS ALSO BROKEN OR BREAKING. I AM CURRENTLY SEEKING ADVICE FROM DOCTORS HERE IN THE U.S. ON WHAT TO DO, NOW THAT ONE OR BOTH OF THE M6 ARTIFICIAL DISCS HAVE BROKEN. MY NEXT APPOINTMENT FOR THE PROBLEM IS (B)(6) AT THE (B)(6) CENTER. PLEASE FEEL FREE TO CONTACT ME ABOUT THIS MATTER TO GET WHATEVER INFORMATION YOU NEED FOR TRACKING THE FAILURE(S) OF SPINAL KINETICS M6 DEVICES.