NEOCIS GUIDANCE SYSTEM
Received Sep 19, 2025 · Event occurred May 7, 2025
Report 3012787974-2025-80096 · MDR key 23103020
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED. THE IMPLANT FAILURE WAS REPORTED BY THE USER. LOGFILE ANALYSIS WAS PERFORMED AND THERE WAS NO INDICATION OF A LOSS OF ACCURACY OF THE DEVICE OR DEVICE ERROR THAT COULD HAVE RESULTED IN THE ISSUE NOTED. A DEFINITIVE ROOT CAUSE FOR THE IMPLANT FAILURE COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. PER LOGFILES, THE OSTEOTOMY WAS COMPLETED AND THE IMPLANT WAS PLACED WITH THE DEVICE TO A MAX DEPTH OF 12.48MM. POSSIBLE REASONS FOR IMPLANT FAILURE COULD BE ASSOCIATED WITH INSUFFICIENT BONE QUALITY, POOR ORAL HYGIENE, OVERHEATING THE BONE DURING THE DRILLING PROCESS, OR OTHER MEDICAL OR LIFESTYLE CHOICES (SMOKING OR OTHER HEALTH CONDITIONS). THE AREA WAS GRAFTED, AND THE IMPLANT WAS REPLACED.
Description of Event or Problem
IT WAS REPORTED THAT ONE IMPLANT FAILED AFTER ROBOTIC PLACEMENT. THE IMPLANT WAS REMOVED AND THE AREA WAS GRAFTED. THE PATIENT WAS SCHEDULED TO RETURN FOR A NEW IMPLANT PLACEMENT.