NEOCIS GUIDANCE SYSTEM
Received Jun 16, 2025 · Event occurred Jun 3, 2023
Report 3012787974-2025-80093 · MDR key 22211800
Device
Product problems
- Calibration Problem
- Calibration Problem
Patient
NA · Female
- Nerve Damage
- Nerve Damage
Narrative
Additional Manufacturer Narrative
LOGFILE ANALYSIS WAS PERFORMED AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE POTENTIAL PATIENT INJURY. BASED ON THE INVESTIGATION RESULTS, THERE WAS NO INDICATION OF CONTACT WITH THE PLANNED NERVE DURING THE USE OF THE DEVICE. A REVIEW OF FINAL PLACEMENT CONCLUDED THAT THE IMPLANTS WERE PLACED OUTSIDE OF THE PLANNED PATH, YET THE IMPLANTS WERE NOT PLACED WITH ROBOTIC GUIDANCE, AND A DIFFERENT IMPLANT SIZE WAS PLACED FREEHAND AT #30 WHEN COMPARED TO THE PLAN. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE THE PLACEMENT OF THE IMPLANT FREEHAND.
Description of Event or Problem
IT WAS REPORTED THAT AFTER DENTAL IMPLANT PROCEDURE WITH YOMI, THE PATIENT REPORTED NUMBNESS AT THE IMPLANT SITE. FOLLOW-UP WITH THE DENTIST NOTED THE PATIENT REPORTED DYSESTHESIA, AND NO MEDICAL INTERVENTION WAS PLANNED AT THIS TIME. BASED ON THE INVESTIGATION RESULTS, THERE WAS NO INDICATION OF CONTACT WITH THE PLANNED NERVE DURING THE USE OF THE DEVICE. A REVIEW OF FINAL PLACEMENT CONCLUDED THAT THE IMPLANTS WERE PLACED OUTSIDE OF THE PLANNED PATH, YET THE IMPLANTS WERE NOT PLACED WITH ROBOTIC GUIDANCE, AND A DIFFERENT IMPLANT SIZE WAS PLACED FREEHAND WHEN COMPARED TO THE PLAN.