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

Model Number GEN1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tooth Fracture (2428)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned.The surgeon indicated the tooth was damaged during the splint removal process.With review of the available information there is no evidence to indicate any device malfunction or performance issues that would impact the reported event.Review of case file indicates that the dental wax was placed on splint prior to application.The neocis guidance system user manual provides instructions that indicate dental material should be placed on teeth prior to attaching splint.Thus, the most probable root cause for the adverse event noted can be associated with user error possible clinical factors that might have contributed to the chipped tooth include any patient pre-existing dental care history.Issues of this nature have been tracked and trended to determine if any additional action is necessary.

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 during removal of the chairside patient splint (cps) that the patient's distal portion of tooth #9 was chipped.No further injury or additional 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
• Manufacturer (Section G): NEOCIS INC.; 530 nw 29th st; miami 33127
• Manufacturer Contact: william tapia ; 530 nw 29th st; miami 33127
• MDR Report Key: 15128649
• MDR Text Key: 296849831
• Report Number: 3012787974-2021-80043
• 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 Operator: Health Professional
• Device Model Number: GEN1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2019
• 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