Description of Event or Problem · 0
IN REGARDS TO DATIX SI 115005. DR. (B)(6) CONFIRMED THE TYPE OF IMPLANT. PER DR. (B)(6): COLLEAGUES, I APOLOGIZE FOR JUMPING THE GUN WITH MY COMMENTS ON THE MEDTRONIC STAND-ALONE DEVICE. AS IT TURNS OUT, I WAS APPROVED AND IMPLANTED A BIOMET-ZIMMER TRELLOS 0-PROFILE INTERBODY CAGE IN THIS PATIENT IN (B)(6). THIS WAS MY DEVICE OF CHOICE IN THIS CASE. IN SURGERY, I FOUND THAT THE SCREW EXTENDING INTO THE C4 VERTEBRAL BODY HAD FRACTURED WITHIN THE DEVICE. UPON REVIEWING IMAGES, THOUGH SUBTLE, THE FRACTURE COULD BE SEEN ON THE CERVICAL X-RAY AND CT SCAN OBTAINED IN NOVEMBER WHEN THE PATIENT BEGAN HAVING THE SYMPTOMS FOR WHICH HE HAD SURGERY TODAY. AS WE MOVE FORWARD AS A GROUP, I THINK IT IS IMPORTANT TO KNOW ABOUT IMPLANT FAILURES TO HELP WITH FUTURE DECISION MAKING. ALSO, I WANTED TO MAKE THE PROPER CHANNELS AWARE IN CASE ZIMMER BIOMET OFFERS SOME REMUNERATION TO THE HOSPITAL OR PATIENT FOR IMPLANT FAILURE. DO I NEED TO DISCUSS THIS WITH ANYONE IN RISK MANAGEMENT? (B)(6), SURGERY TO REPLACE THE DEVICE WAS PERFORMED THE FIRST WEEK OF (B)(6) 2023. PER DR. (B)(6): NO. I'M NOT USING THE STAND-ALONE DEVICE. I'M REMOVING HIS PRE-EXISTING PLATE FROM HIS PREVIOUS SURGERIES AND USING A STANDARD INTERBODY IMPLANT WITH PLATE AND SCREWS, THEN BACKING THE PATIENT UP WITH POSTERIOR SCREWS. THE STAND-ALONE DEVICES WERE DESIGNED TO AVOID THIS EXTENSIVE SURGERY, BUT, IN HIS CASE, IT DIDN'T WORK. (B)(6). (B)(6) INFORMATION IN THE PICTURES SECTION, NOT SURE OF EXACT DATES OF IMPLANT AND EXPLANT.