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

Model Number GEN 1

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

Patient Problem Tooth Fracture (2428)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned.With review of the available information, there is no evidence to indicate any device malfunction or performance issues that would impact the reported event.A possible root cause for the noted chipped tooth can be attributed to user error.The user applied dental wax directly on the splint; the user was made aware that this approach was not recommended and opted to continue without replacing the splint.The neocis guidance system user manual advises the user to apply wax onto the patient's teeth to limit any future difficulties with the removal of the splint.Possible clinical factors that might have contributed to this event include the patient's pre-existing dental care history including indication from the field report that the patient's tooth may have already been chipped prior to surgery.The neocis guidance system user manual contraindicates the use of the system on patients that have insufficient bone or teeth to retain a neocis chairside patient splint (cps) rigidly throughout a surgical procedure.No further injury or additional 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 during removal of the chairside patient splint (cps) a lump of hard acrylic material was left behind on the patient's teeth.Surgeon confirmed that a tooth was chipped during the process of removing the hard acrylic material.The surgeon smoothed the patient's tooth.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 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: 15128582
• MDR Text Key: 296848779
• Report Number: 3012787974-2021-80025
• 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: GEN 1
• 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