MAUDE Adverse Event Report: NEOCIS, INC. YOMI ROBOTIC SYSTEM; DENTAL NAVIGATION SYSTEM

Model Number	GEN 1
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Correction: g3.

• Brand Name: YOMI ROBOTIC SYSTEM
• Common Device Name: DENTAL NAVIGATION SYSTEM
• Manufacturer (Section D): NEOCIS, INC.; 545 nw 26th st unit 700; miami FL 33127
• Manufacturer (Section G): NEOCIS, INC.; 545 nw 26th st unit 700; miami FL 33127
• Manufacturer Contact: william tapia ; 545 nw 26th st unit 700; miami, FL 33127
• MDR Report Key: 18070925
• Report Number: 3012787974-2023-80078
• Device Sequence Number: 7572773
• Product Code: QRY
• UDI-Device Identifier: 00810004900004
• UDI-Public: 00810004900004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: GEN 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 06/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown