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

Model Number GEN 1

Device Problem Off-Label Use (1494)

Patient Problem Implant Pain (4561)

Event Date 06/18/2020

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.The user modified the anterior chairside patient splints (cps) and affixed them to the patient's anterior maxilla and mandible using bone screws.The clinical service representative (csr) informed the user that this was contraindicated use of the device because the patient did not have stable teeth to support the cps.The user decided to proceed with his own clinical judgment.After the case, the user promptly sent the patient for a cone beam computed tomography (cbct) scan due to implant placement concerns.The user was unable to confirm that the fixation screw had interfered with the lingual mandibular artery.One of the screws appeared to be very close to one of the implants, however he stated that it was not touching the implant.A new implant was, therefore, placed free hand.The most probable root cause for the adverse event noted can be associated with user error.Possible clinical factors that might have contributed to this event include the patient's pre-existing dental care history.No further injuries 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 that during a dental implant procedure with the neocis guidance system (ngs), the patient experienced significant bleeding and some pain resulting from off label use of the chairside patient splint (cps).The patient was placed in a separate room applying ice and pressure to alleviate the pain and contain the bleeding.After the patient took a cbct scan, one of the screws used to fix the cps onto the patient appeared to be very close to one of the implants, however the user stated that it was not touching the implant.A new implant was placed free hand.No further injuries 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: 15128623
• MDR Text Key: 296849331
• Report Number: 3012787974-2021-80032
• 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: 06/20/2019
• 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