YOMI ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE POSTERIOR YOMILINK TEETH WAS NOT RETURNED. REVIEW WITH THE SURGEON CONFIRMED THE DAMAGE TO THE TOOTH AND THE REMOVAL OF THE BRIDGE. PER THE YOMILINK TEETH USER MANUAL ADDENDUM, THE PLACEMENT OF THE YOMILINK IS CONTRAINDICATED FOR PATIENTS WHO EXHIBIT PERIODONTAL DISEASE, INCLUDING LOOSE TEETH AND INFLAMED TISSUE. THE SURGEON CONFIRMED THE PATIENT HAD A HISTORY OF PERIODONTAL DISEASE. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE ROOT CAUSE APPEARS TO BE USE ERROR.

Description of Event or Problem

DURING A YOMILINK TEETH (YLT) REMOVAL PROCEDURE, A TOOTH AND A BRIDGE WERE INADVERTENTLY REMOVED. THE PATIENT'S MEDICAL HISTORY INCLUDES EXTENSIVE PRIOR PERIODONTAL WORK. THE PATIENT WAS SUBSEQUENTLY REFERRED TO A GENERAL PRACTITIONER FOR DENTAL TREATMENT. NO FURTHER PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.