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

Model Number	DRW-1000-00
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a dental implant procedure with yomi, the patient reported numbness around the implant site.Follow-up with the customer noted the patient remains symptomatic and no medical intervention was planned at this time.The yomi system was used for surgical planning and osteotomies, but the implants were not placed with robotic guidance.
Additional Manufacturer Narrative
Device was not returned.No additional information on the patient's condition could be obtained at this time.The yomi system was used for surgical planning and osteotomies, but the implants were not placed with robotic guidance.A review of post operative files showed the implant was placed outside of the planned path.It was confirmed that the yomilink bone was used off-label, with only two screws, where the minimum is three.This off-label use increases the risk of a link shift and impacts the system accuracy.Other possible contributing factors include tracker end effector not being seated properly on the kinematic mount or not connected properly to the patient tracker arm, the system being out of calibration, or incorrect tool mismeasurement.Review of the case noted the user deleted the automatically segmented nerve and defined a custom nerve.The event was attributed to user error.

• 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: jorge fernandes ; 545 nw 26th st; unit 700; miami, FL 33127
• MDR Report Key: 25681057
• Report Number: 3012787974-2026-80099
• Device Sequence Number: 14616681
• Product Code: PLV
• UDI-Device Identifier: 00810004900004
• UDI-Public: (01)00810004900004
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K1611399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: 06/10/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2024
• 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: Unknown