SI BONE TITANIUM IMPLANTS

Description of Event or Problem

THE SURGEON THAT PERFORMED MY SI JOINT FUSION SURGERY (DR. (B)(6)) WITH TITANIUM IMPLANTS MANUFACTURED BY SI-BONE DID NOT INSERT THE THREE IMPLANTS IN THE CORRECT POSITION. AS A RESULT, MY PAIN BEGAN TO INCREASE/GO BACK TO PRE-SURGERY LEVELS. DR. (B)(6) DID NOT SERIOUSLY LISTEN TO MY COMPLAINTS OF INCREASING PAIN LEVELS. I REPEATEDLY TOLD HIM FOR MONTHS THAT I FELT SOMETHING WAS NOT RIGHT. IN HINDSIGHT, MY INCREASING PAIN LEVELS WERE MOST LIKELY DUE TO 2 OF THE 3 IMPLANTS MOVING OUT OF POSITION. AFTER 7 MONTHS OF THE SITUATION GETTING WORSE INSTEAD OF BETTER, I INSISTED UPDATED CT SCANS BE ORDERED. UNTIL THIS POINT, DR. (B)(6) HAD ONLY USED X-RAYS TO VIEW THE JOINT. THE SCANS CONFIRMED MY WORST SUSPICIONS, THAT THE FUSION HAD FAILED DUE TO THE MOVEMENT OF THE 2 IMPLANTS THAT HAD BACKED OUT OF POSITION. ONLY THE FIRST/HIGHEST IMPLANT WAS SPANNING THE JOINT RENDERING THE REMAINING IMPLANTS USELESS. I WAS DEVASTATED WITH THIS NEWS. THE SURGEON TOLD ME HE HAD PERFORMED ABOUT 30 SI JOINT FUSION SURGERIES USING THE SI BONE IMPLANTS AND HAD NEVER DEALT WITH A FAILED FUSION OUTCOME UNTIL MINE HAPPENED. HE OFFERED TO DO A REVISION SURGERY TO REMOVE THE FAILED IMPLANTS USING THE SAME SI BONE IMPLANTS! AS HE REPORTEDLY HAD NEVER DONE THIS TYPE OF REVISION SURGERY, I WAS NOT GOING TO LET HIM OPERATE/EXPERIMENT ON ME TO ATTEMPT TO FIX THE PROBLEM. AS A RESULT, I ENDURED A LOT OF ADDITIONAL PAIN AND SUFFERING DUE TO THIS HORRIBLE EXPERIENCE. AT FIRST, I THOUGHT PERHAPS HIS INEXPERIENCE WAS TO BLAME UNTIL I DISCOVERED A VERY SIMILAR SITUATION HAPPENED TO ANOTHER PATIENT WHO REPORTED IT TO YOU. I BELIEVE IN MY CASE THE DOCTOR PERFORMED THE SURGERY AS TRAINED USING THE SI BONE TECHNOLOGY AND THEIR IMPLANTS. THE IMPLANTS APPEARED TO HAVE BEEN PROPERLY INSERTED (PER THE SURGEON'S MEDICAL RECORDS) YET THEY SHOULD NOT HAVE MOVED OUT OF POSITION THAT QUICKLY CAUSING THE FUSION TO FAIL WITHIN ONLY A FEW MONTHS. I DID HAVE A LOCAL NEUROSURGEON (ALMOST 1 YEAR LATER) PERFORM A REVISION SURGERY THAT REQUIRED THE INSERTION OF 2 TITANIUM SCREWS TO SUPPORT THE FAILED IMPLANTS. THE 2ND SI JOINT APPEARS TO HAVE FUSED ENOUGH TO BE CONSIDERED A SUCCESS. UNFORTUNATELY, I STILL HAVE ONGOING SI JOINT PAIN SO FROM MY PERSPECTIVE NEITHER SURGERY FULLY STABILIZED THE JOINT AS INTENDED. FDA SAFETY REPORT ID# (B)(4).