NEOCIS GUIDANCE SYSTEM

Additional Manufacturer Narrative

RATIONALE FOR DECISION TO CEASE REPORTING: GIVEN THAT NO EVENTS HAVE MET THE DEFINITION OF DEATH OR SERIOUS INJURY DURING THE PAST TWO (2) YEARS AND TEN (10) MONTHS, AND BASED ON THE EVALUATIONS FROM QUALIFIED MEDICAL PROFESSIONALS, NEOCIS CONCLUDES THAT CONTINUED REPORTING OF ADVERSE EVENTS RELATED TO DAMAGE TO BONY ANATOMY FROM IMPROPER IMPLANT PLACEMENT IS NOT NECESSARY. IN ADDITION, NEOCIS HAS UPDATED SW-0185-RC MASTER HARMS LIST TO DOWNGRADE THE HARM ASSOCIATED WITH DAMAGE TO BONY ANATOMY FROM IMPROPER IMPLANT PLACEMENT FROM A HARM OF S3 SERIOUS TO S2 MINOR.

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES ONLY. UPDATES BASED ON UDI/MDR DATA QUALITY NOTIFICATION RECEIVED ON DECEMBER 13, 2024.

Description of Event or Problem

AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS NOT IN THE LOCATION EXPECTED BY THE USER 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.