Description of Event or Problem · 1
NEEDED SURGERY BECAUSE OF MEDICAL DEVICE (PEDICLE SCREW) FAILING. HAD SURGERY PERFORMED ON (B)(6) 2014 (ACDF) CERVICAL FUSION AT C5-C6 AREA. EVERYTHING SEEMED GREAT AND PAIN FREE WENT TO WORK ON (B)(6) 2016, PAIN STARTED IN NECK AND SHOULDER. WENT TO ER THREE TIMES OVER WEEKEND AS PAIN IN "INCU EASED" AND RIGHT RING FINGER AND SMALL FINGER BECAUSE NUMB AND PAINFUL. SUBSEQUENT TESTS, MRI'S, X-RAYS, EMG TESTS SHOWED A BROKEN PEDICLE SCREW AND A BROKEN OUT PART OF THE VERTEBRAE. NERVE TESTS SHOW 50 AND 75% LOSS OF NERVE FUNCTION IN RING AND SMALL FINGER. THIS IS PERMANENT AND PAINFUL. FUSION FAILED AND CORRECTIVE SURGERY WAS NEEDED. NUVASIVE DID NOT REPORT THIS WITH IN 30 DAYS, STATED NO ADVERSE EVENT, AND PROVIDED FALSE INFO SUCH AS DATE OF SURGERY AND DATE OF EVENT. ADD'L NOTE: I AM DOING THIS FORM BECAUSE: NUVASIVE, INC., WAS NOTIFIED OF THEIR SCREW BREAKING SHORTLY AFTER IT BROKE AROUND (B)(6) 2016. THEY WERE SENT DRS REPORTS, X-RAYS, MRI'S. I WAS IN SEVERE PAIN FOR 2 MONTHS. I COULD NOT WORK FOR 20 WKS. I HAVE PERMANENT SEVERE NERVE DAMAGE AND PAIN. I NEEDED CORRECTIVE VERY PAINFUL CERVICAL FUSION SURGERY. I HAVE NOT HELD A JOB SINCE THIS EVENT. I DEAL WITH PAIN AND DEPRESSION EVERYDAY. FOR NUVASIVE, INC. TO SAY NO ADVERSE EVENT IS TOTALLY FALSE. PURPOSELY PROVIDING FDA WITH OTHER FALSE INFO IS WRONG ALSO. THANK YOU.