NEOCIS GUIDANCE SYSTEM
Received Sep 19, 2025 · Event occurred May 9, 2025
Report 3012787974-2025-80094 · MDR key 23103039
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THREE IMPLANTS FAILED AFTER ROBOTIC PLACEMENT. NO ADDITIONAL INFORMATION COULD BE OBTAINED ASSOCIATED WITH THE CASE OR PATIENT OUTCOME.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED. THE IMPLANT FAILURES WERE 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 LIMITED INFORMATION AVAILABLE. PER LOGFILES, SIX OSTETOMIES WERE COMPLETED PER PLAN AND FIVE IMPLANTS WERE PLACED PARTIALLY ROBOTICALLY. 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). NO ADDITIONAL INFORMATION COULD BE OBTAINED ASSOCIATED WITH THE CASE OR PATIENT OUTCOME.