NEOCIS GUIDANCE SYSTEM
Received Oct 16, 2024 · Event occurred Sep 19, 2024
Report 3012787974-2024-80089 · MDR key 20465135
Device
Product problems
- Calibration Problem
- Calibration Problem
Patient
47 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS BUCCAL COMPARED TO THE SURGICAL PLAN. A POST-OPERATIVE ASSESSMENT WITH THE SYSTEM'S LOG FILES WAS COMPLETED AND A SYSTEM ACCURACY CHECK WAS COMPLETED. A DEFINITIVE ROOT CAUSE FOR THE INACCURACY REPORTED COULD NOT BE DETERMINED, THERE WAS NO INDICATION OF A DEVICE MALFUNCTION BASED ON INVESTIGATION. THE SURGEON REMOVED THE IMPLANT AND REPLACED IT BY HAND. NO FURTHER MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS ISSUE. THE HANDPIECE IS A STANDARD 3RD PARTY INSTRUMENT USED WITH YOMI NOT MANUFACTURED BY NEOCIS.
Additional Manufacturer Narrative
UDI RELATED DATA QUALITY UPDATES ONLY. UPDATES BASED ON UDI/MDR DATA QUALITY NOTIFICATION RECEIVED ON 13TH DEC 2024.