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	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
After a guided procedure, it was found that the implant placement was not according to the surgical plan.The surgeon updated the osteotomy and completed the procedure in a freehand manner.Based on an analysis of the system log files, it was found that the most likely root cause of this event is the fiducial array was not connected properly by the user during the patient's pre-operative ct scan.A secure fiducial array during the ct scan is required in order to ensure accurate image registration to the physical space of the patient.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: 18250492
• Report Number: 3012787974-2023-80081
• Device Sequence Number: 20483234
• Product Code: PLV
• UDI-Device Identifier: 00810004900004
• UDI-Public: 00810004900004
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: 11/13/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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