Description of Event or Problem · 0
WHILE USING THE YOMI ROBOTIC-ASSISTED IMPLANT PLACEMENT DEVICE, I ENCOUNTERED GREAT DIFFICULTY IN REACHING FULL DEPTH FOR THE OSTEOTOMY PLANNED FOR A DENTAL IMPLANT IN THE SITE OF TOOTH NUMBER 19. WHEN FULL DEPTH WAS FINALLY ACHIEVED, I PLACED THE DENTAL IMPLANT OF THE COMPUTER ASSISTED DESIGN-PLANNED LENGTH IN THE SITE. CAREFUL REVIEW OF A POST OPERATIVE RADIOGRAPH REVEALED THAT THE DEPTH OF THE IMPLANT OSTEOTOMY AND SUBSEQUENT POSITION OF THE DENTAL IMPLANT WERE APPROXIMATELY 3 MM DEEPER THAN PLANNED, WHICH WOULD HAVE BEEN DIFFICULT OR IMPOSSIBLE TO RESTORE WITH A DENTAL CROWN. THIS WAS REMEDIED BY HAVING THE PATIENT RETURN FOR A REPEAT OPERATION, WHEN I REMOVED THE ORIGINAL IMPLANT AND REPLACED IT WITH AN IMPLANT LONGER BY 3 MM. THIS 3 MM DEPTH DEVIATION PUT THE IMPLANT DANGEROUSLY CLOSE TO THE INFERIOR ALVEOLAR NERVE, ALTHOUGH THE NERVE WAS FORTUNATELY NOT DAMAGED. I REPORTED THIS DEPTH DEVIATION TO NEOCIS, AND THEIR ANALYSIS CONCLUDED THAT THE DEPTH DEVIATION WAS ONLY 1.2 MM, WHICH I AM CONFIDENT UNDERSTATES IT SIGNIFICANTLY. MY MEASUREMENT OF THE POST OPERATIVE IMAGING COMPARED TO THE PREOPERATIVELY PLANNED SITE SHOWED A 3 MM DISCREPANCY. IT WAS ALSO CLINICALLY EVIDENT THAT THE IMPLANT WAS SIGNIFICANTLY DEEPER THAN PLANNED. I WAS UNAWARE OF ANY DEVICE MALFUNCTION THAT WOULD HAVE CAUSED THIS DEPTH DEVIATION. NEOCIS CHECKED AND FOUND THE ROBOT TO BE PROPERLY CALIBRATED. 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 ENDANGERED THE PATIENT. I AM LEFT NOT KNOWING WHETHER THIS 3 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 COMPOUNDED BY SUBSEQUENT ADVERSE EVENTS WITH THE 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 ALSO CONCERNED ABOUT THE SIGNIFICANT UNDERSTATING OF THIS DEPTH DEVIATION IN THE NEOCIS ENGINEERING ANALYSIS. POST OPERATIVE THREE-DIMENSIONAL IMAGING AND CLINICAL INSPECTION CLEARLY SHOWED A DEVIATION MORE THAT DOUBLE THAT CONCLUDED BY NEOCIS, AND THE 3 MM DEVIATION EXPERIENCED IS WELL BEYOND AN ACCEPTABLE LIMIT. I HAVE A CONCERN 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. BASED SOLELY ON MY COLLECTIVE EXPERIENCE WITH THIS TECHNOLOGY, USING IT IN THE WAY WE WERE TRAINED AND CLOSELY FOLLOWING ALL PROTOCOLS, MY CONCLUSION IS THAT THIS PRODUCT SHOULD PROBABLY NOT BE ON THE MARKET FOR USE IN SUCH DENTAL IMPLANT CASES. IT OFFERS TRULY IMPRESSIVE TECHNOLOGY, BUT IT DOES NOT CONSISTENTLY MEET MY OWN LONG-ESTABLISHED STANDARDS, OR THE STANDARDS CLAIMED BY NEOCIS, OF PRECISION IN DENTAL IMPLANT PLACEMENT. NEOCIS CONTINUES TO MAKE MARKETING CLAIMS THAT WERE NOT SUBSTANTIATED CLINICALLY IN OUR USE OF THE DEVICE. WE ENCOUNTERED TRUE AND ACCEPTABLE PRECISION IN ONLY 50-60% OF OUR YOMI IMPLANT CASES.