Description of Event or Problem · 1
I HAD AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PERFORMED IN 2008 WITH USE OF THE "MYSTIQUE" PLATE DISTRIBUTED TO FUSE C6-C7. POST-SURGERY, I HAD NO RELIEF OF RADICULAR SYMPTOMS AND ONSET OF DYSPHAGIA. ONCE I SEEKED MEDICAL ADVICE, I WAS INFORMED BY TWO SEPARATE DOCTORS THAT THEY BELIEVED THE DEVICE FAULTED, AND I HAD A NON-UNION OF VERTEBRAL BODIES RESULTING IN COLLAPSE OF THE FUSION LEVEL, WORSENING OF SYMPTOMS, ADJACENT LEVEL COLLAPSE, AND I WAS IN NEED OF REQUIRING REMOVAL OF DEVICE AND IMPLANTATION OF NEW TITANIUM DEVICE. WHILE SEEKING OPINIONS FROM ORTHOPEDIC SURGEONS, I WAS INFORMED BY MY SURGEON THAT HE HAD SPOKEN WITH THE MEDTRONIC'S REPRESENTATIVE WHO REPORTED THAT THE MYSTIQUE PLATE WAS NO LONGER BEING USED DUE TO SEVERAL NON UNIONS AND COMPLICATIONS BEING REPORTED BY PATIENTS REQUIRING ADDITIONAL SURGERIES. AFTER MY NEXT SURGERY, I WAS INFORMED BY MY DOCTOR THAT I WAS INDEED NOT FUSED DUE TO THE MYSTIQUE PLATE BEING USED. I NOW HAVE A TITANIUM PLATE TO FUSE C5-C7 LEVELS. IN ADDITION, IT WAS FOUND DURING SURGERY THAT THE DEVICE HAD CREATED A SAQ-LIKE STRUCTURE BETWEEN MY ESOPHAGUS AND VERTEBRAE THAT WAS MOST LIKELY PRODUCING THE DYSPHAGIA. I HAVE NOW HAD RESOLUTION OF RADICULAR SYMPTOMS AND DYSPHAGIA. DATES OF USE: 2008 -- 2009. DIAGNOSIS OR REASON FOR USE: VERTEBRAL DISC HERNIATION AND RADICULOPATHY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.