Description of Event or Problem · 0
WHILE USING THE YOMI ROBOTIC-ASSISTED IMPLANT PLACEMENT DEVICE, I STARTED THE OSTEOTOMY FOR AN IMMEDIATE IMPLANT FOR TOOTH NUMBER 31 AFTER EXTRACTING TOOTH NUMBER 31. I STARTED THE OSTEOTOMY USING THE YOMI ROBOT WITH A SIDE-CUTTING 2.0MM PILOT DRILL, BECAUSE I WAS TRYING TO ENGAGE THE INTERRADICULAR BONE OF THE EXTRACTION SOCKET. AS I ENLARGED THE HOLE'S DIAMETER I NOTED THAT THE OSTEOTOMY WAS FOLLOWING THE DISTAL ROOT SOCKET AT A 15-20 DEGREE DEVIATION THAT WAS ALSO 2-3MM POSTERIOR TO THE PLANNED POSITION. I MADE THREE ATTEMPTS TO ENGAGE THE INTERRADICULAR BONE WITH THE SIDE CUTTING DRILL USING YOMI ROBOTIC GUIDANCE, ALL WITHOUT SUCCESS. I THEN DISENGAGED THE ROBOT AND MANUALLY REPOSITIONED THE OSTEOTOMY TO THE PROPER POSITION AND ANGLE, AND PLACED THE IMPLANT IN THE CORRECT POSITION. PRIOR TO DISENGAGING THE ROBOT'S TRACKER ARM, I CAREFULLY CHECKED THE ATTACHMENT OF THE TOOTH LINK MECHANISM TO THE OPPOSITE SIDE OF THE DENTAL ARCH AND IT WAS SECURE, WHICH RULES OUT A LOOSE CONNECTION. THE ROBOT WAS PROPERLY CALIBRATED WHEN NEOCIS CHECKED IT. I AND MY STAFF HAD RECENTLY BEEN FULLY TRAINED WITH USE OF THE ROBOT, AND WE WERE CAREFUL TO OBSERVE ALL PROPER PROTOCOLS. WE WERE REPEATEDLY PROMISED "SUBMILLIMETRIC ACCURACY" FOR DENTAL IMPLANT OSTEOTOMIES PREPARED WITH THIS ROBOTIC ASSISTANCE. THIS CASE NOT ONLY SHOWED FAILURE TO ACHIEVE SUBMILLIMETRIC ACCURACY, BUT WAS A DEVIATION THAT COULD HAVE ENDANGERED THE PATIENT WITH AN IMPLANT NOT IN THE CORRECT ANGLE OR POSITION FOR RESTORING. I AM LEFT NOT KNOWING WHETHER THIS GREATER THAN 2 MM DEVIATION WAS DUE TO A DEFICIENCY OF THE TECHNOLOGY ITSELF, A DEFECTIVE UNIT, IMPROPER CALIBRATION, MISUSE OF THE UNIT BY ME OR MY STAFF, IMPROPER TRAINING, OR A COMBINATION OF THE ABOVE. THIS ADVERSE EVENT WAS ACCENTUATED BY ADVERSE EVENTS WITH THE YOMI SURGICAL ROBOT ON NUMEROUS OTHER PATIENTS, WHICH I WILL DESCRIBE IN SEPARATE REPORTS. AFTER USING THE ROBOT FOR APPROXIMATELY 40 CASES OVER MORE THAN TWO MONTHS, I CONCLUDED THAT PATIENTS WERE BEING PUT AT RISK BY CONTINUED USE OF THE ROBOT. I INFORMED NEOCIS THAT I HAD STOPPED USING THE ROBOT BECAUSE I WAS CONCERNED ABOUT PATIENT SAFETY. NEOCIS BEGRUDGINGLY ACCEPTED THE UNIT BACK, BUT THEIR ATTITUDE SEEMED ONE OF INDIFFERENCE ABOUT MY SAFETY CONCERNS, SEEMINGLY BECAUSE SALES ARE GOOD, THEY "CAN'T MAKE THEM FAST ENOUGH", AND "THIS JUST DOESN'T HAPPEN". I AM CONCERNED ABOUT PATIENT SAFETY WITH THE YOMI ROBOT IN CASES SIMILAR TO THE ONES I WAS DOING, WHICH WERE PRIMARILY SINGLE IMPLANTS, WITH AN OCCASIONAL TWO- OR THREE-IMPLANT CASE, USING THE NEOCIS TOOTH LINK SYSTEM FOR ROBOT POSITIONING AND CALIBRATION. I AM ALSO CONCERNED ABOUT HOW NEOCIS PRESENTED FDA CONTRAINDICATIONS FOR USING THE YOMI DEVICE, WHICH INCLUDE PREEXISTING CROWNS, BRIDGES OR IMPLANTS ON THE OPPOSITE SIDE OF THE ARCH, OR TEMPOROMANDIBULAR JOINT PROBLEMS. A VERY SMALL PERCENTAGE OF POTENTIAL IMPLANT PATIENTS ARE WITHOUT ANY OF THESE CONTRAINDICATIONS, WELL UNDER FIVE PERCENT IN MY EXPERIENCE, SO THE OVERWHELMING MAJORITY OF PATIENTS TREATED NEED THE ROBOT USED IN AN OFF-LABEL CAPACITY. NEOCIS WAS NOT FORTHCOMING WITH THESE CONTRAINDICATIONS PRIOR TO DELIVERY OF THE UNIT, AND I DID NOT SEE ANY MENTION OF THEM IN MATERIAL I HAD ACCESS TO PRIOR TO PURCHASE AND DELIVERY OF THE ROBOT. BASED ON MY COLLECTIVE EXPERIENCE WITH THIS TECHNOLOGY, USING IT IN THE WAY WE WERE TRAINED AND CLOSELY FOLLOWING ALL PROTOCOLS, I CONCLUDED THAT THIS PRODUCT SHOULD PROBABLY NOT BE ON THE MARKET FOR SIMILAR DENTAL IMPLANT USE. NEOCIS CONTINUES TO MAKE MARKETING CLAIMS THAT WERE NOT SUBSTANTIATED CONSISTENTLY DURING OUR CLINICAL USE OF THE ROBOT. WE ENCOUNTERED TRUE AND ACCEPTABLE PRECISION IN ONLY 50-60% OF OUR YOMI IMPLANT CASES.