MAUDE Adverse Event Report: NEOCIS, INC. NEOCIS GUIDANCE SYSTEM; Dental stereotaxic instrument

Model Number	GEN 1
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Sinus Perforation (2277)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a dental implant procedure with the neocis guidance system (ngs), the surgeon attempted a vertical sinus lift with increased implant height by 3mm using drills in reverse.During the procedure, the sinus membrane resistance was not felt resulting in perforation.The surgeon bone grafted and sutured the site to prevent further injury.The implant was not placed and the patient will return at a later date for the implant placement.No additional injury or medical intervention was reported as a result of this event.There is no indication of a device malfunction.The procedure is not an approved indication for use.This issue is being reported in an abundance of caution.

• Brand Name: NEOCIS GUIDANCE SYSTEM
• Common Device Name: Dental stereotaxic instrument
• 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
• MDR Report Key: 21132310
• Report Number: 3012787974-2025-80092
• Device Sequence Number: 7517200
• Product Code: PLV
• UDI-Device Identifier: 00810004900004
• UDI-Public: 810004900004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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: GEN 1
• 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: 12/11/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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
• Patient Sex: Unknown