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

Model Number GEN 1

Device Problems Calibration Problem (2890); Overcorrection (3006)

Patient Problem Failure of Implant (1924)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

Completion of the investigation to determine root cause is currently pending.An additional narrative will be provided with a follow-up report.

Event Description

It was reported that after the user's implant placement with the neocis guidance system (ngs), the user was not happy with the final implant placement.The user decided to remove the implant and replace it by hand.No further intervention was reported as a result of this event.An investigation to determine root cause is currently in process.This issue is being reported in advance of completion of the investigation in an abundance of caution to be in full compliance with 21 part 803 mdr.

Manufacturer Narrative

The following narrative is follow-up information to an mdr previously submitted by neocis.Functional testing of the returned neocis system was performed and it was noted that the guidance arm appeared to have a 0.5mm deviation in accuracy when approached from opposite directions.Logfile analysis was performed and there was no indication of system errors during the procedure.A definitive root cause for the loss of accuracy noted could not be determined.Possible root causes for the loss of accuracy noted could be attributed to a movement of the splint during the procedure, improper handpiece placement or issues related to planning.Field servicing was performed following this event and the system was replaced.There was no indication of damage to the anatomy, the implant was removed and replaced by hand.No further medical or surgical 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
• MDR Report Key: 11829589
• MDR Text Key: 250834640
• Report Number: 3012787974-2021-80012
• Device Sequence Number: 1
• Product Code: PLV
• UDI-Device Identifier: 00810004900004
• UDI-Public: 00810004900004
• Combination Product (y/n): N
• PMA/PMN Number: K202100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2021
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention