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

Model Number	GEN 1
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
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: 18070841
• Report Number: 3012787974-2023-80077
• Device Sequence Number: 20729210
• Product Code: QRY
• UDI-Device Identifier: 00810004900004
• UDI-Public: 00810004900004
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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?: Yes
• 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: 11/05/2023
• Supplement Report FDA Received Date: 06/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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