YOMI ROBOTIC SYSTEM
Received Nov 5, 2023 · Event occurred Oct 6, 2023
Report 3012787974-2023-80077 · MDR key 18070841
Device
Product problems
- Off-Label Use
- Off-Label Use
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 THE IMPLANT PLACEMENT WAS NOT ACCORDING TO THE SURGICAL PLAN. BASED ON AN ANALYSIS OF THE SYSTEM LOG FILES, IT WAS FOUND THAT THE SYSTEM WAS USED OFF LABEL. SPECIFICALLY, THE SPLINT USED REQUIRES A MINIMUM OF 3 BONE SCREWS TO ENSURE ACCURATE TRACKING OF PATIENT MOVEMENT, HOWEVER THE SURGEON USED ONLY 2 BONE SCREWS. ALTHOUGH THE SPLINT SEEMED STABLE DURING THE PROCEDURE PER FEEDBACK FROM THE FIELD, LIKELY ROOT CAUSE OF THIS EVENT IS SPLINT MOVEMENT DUE TO NOT USING THE REQUIRED MINIMUM OF 3 BONE SCREWS. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION TO BE IN COMPLIANCE WITH THE MDR REGULATION.