MAUDE Adverse Event Report: NEOCIS INC. NEOCIS GUIDANCE SYSTEM; YOMI

Model Number	DRW-1000-00
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	06/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Logfile analysis was performed and there was no indication of a device malfunction that could have contributed to the potential patient injury.Based on the investigation results, there was no indication of contact with the planned nerve during the use of the device.A review of final placement concluded that the implants were placed outside of the planned path, yet the implants were not placed with robotic guidance, and a different implant size was placed freehand at #30 when compared to the plan.The root cause of the issue was determined to be the placement of the implant freehand.
Event or Problem Description
It was reported that after dental implant procedure with yomi, the patient reported numbness at the implant site.Follow-up with the dentist noted the patient reported dysesthesia, and no medical intervention was planned at this time.Based on the investigation results, there was no indication of contact with the planned nerve during the use of the device.A review of final placement concluded that the implants were placed outside of the planned path, yet the implants were not placed with robotic guidance, and a different implant size was placed freehand when compared to the plan.

• Brand Name: NEOCIS GUIDANCE SYSTEM
• Common Device Name: YOMI
• 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: jorge fernandes ; 545 nw 26th st; unit 700; miami, FL 33127
• MDR Report Key: 22211800
• Report Number: 3012787974-2025-80093
• Device Sequence Number: 8619849
• Product Code: PLV
• UDI-Device Identifier: 00810004900004
• UDI-Public: 810004900004
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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: DRW-1000-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Female