BRYAN® CERVICAL DISC SYSTEM

Additional Manufacturer Narrative

B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MEDTRONIC LEGAL REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT BRYAN CERVICAL DISC FAILED WITHIN 6-8 MONTHS OF IMPLANTATION AND PATIENT HEARD "SQUEAKING" AND DEVELOPED SYMPTOMS OF BEING UNABLE TO MOVE NECK. PATIENT HAD PERMANENT SPINAL CORD DAMAGE, DAMAGED NERVE AND COULD NOT FEEL LEFT ARM. THE DISC COULD NOT REMOVED BECAUSE THE BONES HAD GROWN OVER AND THE HOLE WOULD BE SO BIG IF IT WERE REMOVED. PATIENT COULD BARELY WALK. SECOND SURGERY WAS NEEDED AND HAPPENED POSTERIORLY BECAUSE THE DISC WAS PUSHING OUT OF SPINAL COLUMN. RODS AND SCREWS WERE ADDED TO KEEP IT FROM INGESTING INTO THEIR THROAT- SO IT DIDN'T POP OUT. X-RAY 6 MONTHS AGO SHOWED THAT THE DISC HAD MOVED MILLIMETERS - AND WAS EJECTING ITSELF FROM THE SPINAL COLUMN. THERE WAS CHRONIC PAIN FROM THE NECK THAT RADIATES TO CHEST AND DOWN TO "CROTCH," LEG PAIN, AND NEUROPATHY AND CURRENTLY ON CHRONIC PAIN MEDICATIONS. OTHER SYMPTOMS RELATED TO THE DISC WERE INSOMNIA, ANXIETY, STRESS, WORRY. ALSO, PATIENT HAD A NEW SYMPTOM OF HEART RATE SHOOTING UP TO AN AVERAGE OF 150 TO 160 BPM, HIGHEST WAS 182. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.