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 04/01/2022

Event Type  Injury  

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.Upon removal of upper left yomi link at the end of surgery, crown and part of tooth fractured off endodontically treated tooth.Patient was referred to a restorative doctor.No further injury or additional medical intervention was reported as a result of this event.

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 damaged tooth can be associated patient's pre-existing compromised tooth.No further injury or additional medical intervention has been 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: 15128664
• MDR Text Key: 296850065
• Report Number: 3012787974-2022-80052
• 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: K210711
• 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
• 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