MAUDE Adverse Event Report: NEOCIS INC. YOMILINK BONE (UL); DENTAL NAVIGATION SYSTEM

Model Number	YLB UL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
When placing yomi link bone (without robotic guidance), one of the screws penetrated a tooth root.The tooth had been already planned to be extracted but this even is being reported in an abundance of caution.
Additional Manufacturer Narrative
Udi related data quality updates only.Updates based on udi/mdr data quality notification received on december 13, 2024.

• Brand Name: YOMILINK BONE (UL)
• Common Device Name: DENTAL NAVIGATION SYSTEM
• Manufacturer (Section D): NEOCIS INC.; 2800 biscayne blvd #600; miami FL 33137
• Manufacturer (Section G): NEOCIS INC.; 2800 biscayne blvd #600; miami FL 33137
• Manufacturer Contact: william tapia ; 2800 biscayne blvd #600; miami, FL 33137
• MDR Report Key: 17144055
• Report Number: 3012787974-2023-80071
• Device Sequence Number: 11239687
• Product Code: PLV
• UDI-Device Identifier: 00810004900486
• UDI-Public: 00810004900486
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: YLB UL
• Device Catalogue Number: DRW-DRW-1356-01
• Device Lot Number: N/A
• 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: 06/04/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown