Description of Event or Problem · 1
ON (B)(6) 2012 I HAD A STRYKER CERVICAL THORACIC SYSTEM INSTALLED IN MY SPINE TO STABILIZE DISC DETERIORATION FROM PREVIOUS RADIATION USED TO TREAT THYROID CANCER. THE OPERATION WAS NECESSARY BECAUSE THE RISK WAS THERE FOR THE SPINE TO SEPARATE LEAVING ME A POSSIBLE QUADRIPLEGIC OR COULD LEAD TO DEATH. I WAS HOSPITALIZED TWO MORE TIMES FOR (B)(6) INFECTION AND THEN (B)(6). AFTER SIX OR SEVEN MONTHS THE PAIN RETURNED AS BAD AS BEFORE. AFTER MORE TESTING IT APPEARED THAT THE SCREWS AND ANCHORS THAT WERE USED HAD COME LOOSE AND MY NECK HAD SHIFTED FORWARD AGAIN AND THE RISK WAS ONCE THERE AND ANOTHER SURGERY WAS INEVITABLE. AFTER LOSING FAITH IN THE ORIGINAL SURGEON I SOUGHT OUT SOMEONE WHO COULD RECTIFY THE PROBLEM. I DID FIND A HIGHLY SKILLED SURGEON WHO AFTER MOST STUDY AND HESITATION SAID HE WOULD ADD TO THE PREVIOUS EQUIPMENT AND REMOVE THE LOOSENED SCREWS AND ANCHORS. THE PARTS WOULD ALSO BE MADE BY STRYKER SO THEY WOULD BE ABLE TO ATTACH THEM UP. THE OPERATION WENT SMOOTHLY, NO INFECTION, NO PROBLEMS, SO I FELT THE PROBLEM WAS SOLVED AND WOULD NO LONGER BE A THREAT. APPROXIMATELY 6 MONTHS LATER I STARTED TO HAVE A POPPING NOISE IN MY SPINE AND A FEELING OF ELECTRIC SHOCK IN MY SPINE, AND INCREASED PAIN. I RETURNED TO THE SURGEON AND WAS EXTREMELY DISAPPOINTED TO FIND THAT THE TWO 6MM TITANIUM BARS THAT WERE USED TO CONNECT MY SPINE WERE BOTH BROKEN IN TWO. I HAVE A DEEP FEAR OF RETURNING TO THE OPERATING ROOM AND REMOVING ALL THE HARDWARE AND REPLACING IT WITH ANOTHER BRAND, AS THE SURGEON SUGGESTED. ALL THE PARTS WERE MADE BY STRYKER AND ALL THE PARTS WERE FROM THE "OASIS CERVICAL THORACIC SYSTEM". I HAVE MADE SEVERAL ATTEMPTS TO GET THE SERIAL NUMBERS AND LOT NUMBERS FOR THE ORIGINAL PARTS, AFTER I FOUND OUT THAT THIS PARTICULAR SYSTEM HAD PARTS RECALLED TWO MONTHS BEFORE MY SURGERY. I THINK I WAS PREVIOUSLY WRONG IN DOUBTING THE SURGEON AND I THINK THIS IS ALL PRODUCT FAILURE. WHAT CAN I DO ABOUT THIS?