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

Model Number	DRW-2081-02
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The posterior yomilink teeth was not returned.Review with the surgeon confirmed the damage to the tooth and the removal of the bridge.Per the yomilink teeth user manual addendum, the placement of the yomilink is contraindicated for patients who exhibit periodontal disease, including loose teeth and inflamed tissue.The surgeon confirmed the patient had a history of periodontal disease.There is no evidence of a device malfunction.The root cause appears to be use error.
Event or Problem Description
During a yomilink teeth (ylt) removal procedure, a tooth and a bridge were inadvertently removed.The patient's medical history includes extensive prior periodontal work.The patient was subsequently referred to a general practitioner for dental treatment.No further patient injury or medical intervention was reported.

• 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: 25595876
• Report Number: 3012787974-2026-80098
• Device Sequence Number: 5381754
• Product Code: PLV
• UDI-Device Identifier: 00810004900608
• UDI-Public: 00810004900608
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• 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-2081-02
• 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: 05/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown