YOMI ROBOTIC SYSTEM
Received Nov 6, 2023 · Event occurred Oct 5, 2023
Report 3012787974-2023-80078 · MDR key 18070925
Device
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CORRECTION: G3.
Description of Event or Problem
AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT 1 OF 2 IMPLANT PLACEMENTS WERE NOT ACCORDING TO THE SURGICAL PLAN. ONE IMPLANT WAS PLACED BUCCAL TO PLAN. AN ANALYSIS OF THE SYSTEM LOG FILES AND A POST-OP CT SCAN WAS COMPLETED. SOME CONTRIBUTING FACTORS WERE IDENTIFIED I.E., PATIENT WAS OUTSIDE OF THE RECOMMENDED WORK VOLUME, HOWEVER A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. A QUICK CHECK OF THE SYSTEM WAS ALSO PERFORMED AFTER THE PROCEDURE AND THE SYSTEM WAS FOUND TO BE IN GOOD WORKING ORDER. SUCCESSFUL PROCEDURES HAVE BEEN PERFORMED SINCE THIS EVENT HOWEVER FIELD SERVICE WILL STILL BE CONTACTED TO DETERMINE IF SERVICING OF THE SYSTEM IS NEEDED.