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 02/23/2018

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.It was reported that during a dental implant procedure with the neocis guidance system (ngs), the patient incurred a chipped tooth.Issue occured as a result of collision between the patient's anatomy and surgical equipment.There are no implications of a device/system malfunction.No additional patient injury or medical intervention was reported as a result of this event.

Manufacturer Narrative

The device was not returned.Issue appears to have occured as a result of working with metal tools in a constrained anatomical workspace.Per the information obtained from the user, there was no system malfuntion that may have caused or contributed to the incident.Ta potential root cause for the issue noted could be attributed to user error.Possible factors that may have contributed to this issue could be the patient's anatomy and other procedural factors (e.G., excessive patient movement).

• 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: 15128541
• MDR Text Key: 296848652
• Report Number: 3012787974-2021-80019
• 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: K161399
• 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: 12/18/2017
• 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