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

Model Number	DRW-1000-00
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
After a guided procedure and post-operative assessment, it was found that the implant placement was not according to the surgical plan.The surgeon removed the implant and relocated it in a freehand manner.No further medical intervention was reported as a result of this event.
Additional Manufacturer Narrative
Correction: g3.
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 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 33127
• MDR Report Key: 18070782
• Report Number: 3012787974-2023-80075
• Device Sequence Number: 20736998
• Product Code: PLV
• UDI-Device Identifier: 00810004900004
• UDI-Public: 00810004900004
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,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: Not provided
• Supplement Date Received by Manufacturer: 09/08/2023; Not provided
• Initial Report FDA Received Date: 11/05/2023
• Supplement Report FDA Received Date: 06/23/2024; 12/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• 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: Required Intervention
• Patient Sex: Unknown