Description of Event or Problem · 0
WHILE USING THE YOMI ROBOTIC-ASSISTED IMPLANT PLACEMENT DEVICE, I ENCOUNTERED DIFFICULTY IN REACHING FULL DEPTH FOR THE OSTEOTOMY PLANNED FOR A DENTAL IMPLANT IN THE SITE OF TOOTH NUMBER 19. THE PLANNED DEPTH WAS 8.0 MM, BUT THE DEPTH INDICATOR STALLED OUT AT 7.8 MM, DESPITE HEAVY FORCE EXERTED TO ACHIEVE FULL DEPTH. I REMOVED THE DRILL FROM THE OSTEOTOMY SITE AND MANUALLY MEASURED THE DEPTH OF THE PREPARATION, AND FOUND A DEPTH OF SLIGHTLY OVER 10 MM, WHICH WAS MORE THAN 2 MM DEEPER THAN THE ROBOT WAS INDICATING. BECAUSE OF THIS MALFUNCTION. I DISENGAGED THE ROBOT AND FINISHED THE OSTEOTOMY FREEHAND, DRILLING ONLY TO THE PLANNED DEPTH OF 8 MM WITH THE LAST TWO DRILLS, AND SEATED THE IMPLANT AT THE PROPER DEPTH. IF I HAD RELIED ON THE ROBOT TO GUIDE DRILLING TO THE PROPER DEPTH, THE OSTEOTOMY WOULD HAVE BEEN AT LEAST 3 MM TOO DEEP. 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 OF THE TRACKER ARM. 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 YOMI ROBOTIC ASSISTANCE. THIS CASE NOT ONLY SHOWED FAILURE TO ACHIEVE SUBMILLIMETRIC ACCURACY, IT WAS A DEVIATION THAT COULD HAVE ENDANGERED THE PATIENT IF I HAD NOT INTERVENED AND FINISHED THE OSTEOTOMY MANUALLY. 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.