MAUDE Adverse Event Report: NEOCIS INC. NEOCIS GUIDANCE SYSTEM; DENTAL STEREOTAXIC INSTRUMENT

Model Number GEN 1

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Skin Tears (2516)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

The splint was returned.With review of available information, there is no indication of a malfunction of the device.A possible root cause for the event can be attributed to user error.Exceeding the recommended amount of dental material used for placement of the chairside patient splint (cps) may contribute to higher risk of device.The neocis guidance system user's manual includes instructions on placing the cps with proper amount of dental material.No additional injury or medical intervention was reported as a result of this event.

Event Description

Neocis performed retrospective review of product complaints and reevaluated mdr reportability.This report is being submitted as a result of this retrospective review.It was reported that during a dental implant procedure with the neocis guidance system (ngs) the user noted that the dental material used to apply the neocis chairside patient splint (cps) had hardened into a sharp orientation causing it to cut patients cheek slightly.The sharp end of the material was located on the posterior buccal aspect of the splint on the buccal wall.The user applied one stitch to close up the cut.No additional injury or medical intervention was reported as a result of this event.

• Brand Name: NEOCIS GUIDANCE SYSTEM
• Type of Device: DENTAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): NEOCIS INC.; 530 nw 29th st; miami 33127
• Manufacturer (Section G): NEOCIS INC.; 530 nw 29th st; miami 33127
• Manufacturer Contact: william tapia ; 530 nw 29th st; miami 33127
• MDR Report Key: 15128581
• MDR Text Key: 296848769
• Report Number: 3012787974-2021-80024
• Device Sequence Number: 1
• Product Code: PLV
• UDI-Device Identifier: 00810004900004
• UDI-Public: 00810004900004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: GEN 1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention