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 04/27/2021

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.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 crown was deteriorated prior to splint placement.The neocis guidance system user manual contraindicates for use in patients that have insufficient bone or teeth to retain a neocis chairside patient splint (cps) rigidly throughout a surgical procedure.Issues of this nature will be tracked and trended to determine if additional escalation is necessary.

Event Description

It was reported during removal of the chairside patient splint (cps) that the patient's decayed natural crown was removed.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 FL 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: 11891202
• MDR Text Key: 252888880
• Report Number: 3012787974-2021-80014
• 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: K202100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GEN 1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• 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): Disability