YOMI ROBOTIC SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT AFTER A DENTAL IMPLANT PROCEDURE WITH YOMI, THE PATIENT REPORTED NUMBNESS AROUND THE IMPLANT SITE. FOLLOW-UP WITH THE CUSTOMER NOTED THE PATIENT REMAINS SYMPTOMATIC AND NO MEDICAL INTERVENTION WAS PLANNED AT THIS TIME. THE YOMI SYSTEM WAS USED FOR SURGICAL PLANNING AND OSTEOTOMIES, BUT THE IMPLANTS WERE NOT PLACED WITH ROBOTIC GUIDANCE.

Additional Manufacturer Narrative

DEVICE WAS NOT RETURNED. NO ADDITIONAL INFORMATION ON THE PATIENT'S CONDITION COULD BE OBTAINED AT THIS TIME. THE YOMI SYSTEM WAS USED FOR SURGICAL PLANNING AND OSTEOTOMIES, BUT THE IMPLANTS WERE NOT PLACED WITH ROBOTIC GUIDANCE. A REVIEW OF POST OPERATIVE FILES SHOWED THE IMPLANT WAS PLACED OUTSIDE OF THE PLANNED PATH. IT WAS CONFIRMED THAT THE YOMILINK BONE WAS USED OFF-LABEL, WITH ONLY TWO SCREWS, WHERE THE MINIMUM IS THREE. THIS OFF-LABEL USE INCREASES THE RISK OF A LINK SHIFT AND IMPACTS THE SYSTEM ACCURACY. OTHER POSSIBLE CONTRIBUTING FACTORS INCLUDE TRACKER END EFFECTOR NOT BEING SEATED PROPERLY ON THE KINEMATIC MOUNT OR NOT CONNECTED PROPERLY TO THE PATIENT TRACKER ARM, THE SYSTEM BEING OUT OF CALIBRATION, OR INCORRECT TOOL MISMEASUREMENT. REVIEW OF THE CASE NOTED THE USER DELETED THE AUTOMATICALLY SEGMENTED NERVE AND DEFINED A CUSTOM NERVE. THE EVENT WAS ATTRIBUTED TO USER ERROR.