MAUDE Adverse Event Report: NEOCIS, INC. NEOCIS GUIDANCE SYSTEM; DENTAL NAVIGATION SYSTEM

Model Number	DRW-1000-00
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
After a guided procedure, a nobel biocare nobel active implant was placed in a flapless manner in the anterior maxillary central incisor location and was found to be outside the buccal plate.A review of the yomi system's log files did not indicate any system malfunction.The implant's instructions for use were also reviewed which contraindicated the use of this implant for replacing central incisors in the maxilla.This event is therefore being attributed to off label use of the specified implant manufacturer's contraindication statement.The implant is not manufactured by neocis.This report is being filed in an abundance of caution to be in compliance with the mdr regulation.
Additional Manufacturer Narrative
Udi related data quality updates only.Updates based on udi/mdr data quality notification received on 13th dec 2024.

• Brand Name: NEOCIS GUIDANCE 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: william tapia ; 545 nw 26th st unit 700; miami, FL 33127
• MDR Report Key: 18127907
• Report Number: 3012787974-2023-80080
• Device Sequence Number: 6403631
• Product Code: PLV
• UDI-Device Identifier: 00810004900004
• UDI-Public: 00810004900004
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown