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

Model Number GEN 1

Device Problems Calibration Problem (2890); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

An initial investigation of the system log file was performed which demonstrated that the guidance arm movement was requested by the surgeon.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 during a dental implant procedure with the neocis guidance system (ngs), the guidance arm entered into safety pause mode.The user resolved the safety pause mode and noted that the guidance arm made an unwanted movement.The handpiece made minor contact with the patient and the chairside assistant subsequently moved the guidance arm away to avoid any further contact.No injury or additional medical intervention was reported as a result of this event.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 of the event was performed and it was noted that after the safety pause the user selected and acknowledged the movement of the guidance arm to the home left position.Review of the logfiles confirms the guidance arm moved per request and acknowledgement of the user.A possible root cause for the issue noted could be attributed to user error and training.The neocis guidance system user's manual provides a warning before moving the guidance arm with the advanced menu to ensure that the arm is clear of any obstacle within the working volume before selecting the position.The manual also indicates "the patient, user or an assistant is present, move the arm away from the obstacle in free mode before proceeding." no 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
• MDR Report Key: 11891195
• MDR Text Key: 252886113
• Report Number: 3012787974-2021-80013
• 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: 05/26/2021
• 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?: 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