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

Model Number	DRW-1000-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one implant failed after robotic placement.The area was grafted, and the implant was replaced.
Additional Manufacturer Narrative
The device was not returned.The implant failure was reported by the user.Logfile analysis was performed and there was no indication of a loss of accuracy of the device or device error that could have resulted in the issue noted.A definitive root cause for the implant failure could not be determined based on limited information available.Per logfiles, the osteotomy was completed to 10.29mm and the implant was placed with the device to a max depth of 8.43mm.Possible reasons for implant failure could be associated with insufficient bone quality, poor oral hygiene, overheating the bone during the drilling process, or other medical or lifestyle choices (smoking or other health conditions).

• Brand Name: NEOCIS GUIDANCE SYSTEM
• Common Device Name: YOMI
• Manufacturer (Section D): NEOCIS INC.; 545 nw 26th st; unit 700; miami 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: 23103038
• Report Number: 3012787974-2025-80095
• Device Sequence Number: 12700022
• Product Code: PLV
• UDI-Device Identifier: 00810004900004
• UDI-Public: 810004900004
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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: 08/28/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male