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

Model Number GEN 1

Device Problem Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

Review of the event description from the neocis field representative and the system's logfile was performed.It was confirmed that the system paused due to excessive forces recorded during the procedure, as designed.Review confirmed that the user selected to bias the system while the handpiece was in the implant location and after the safety pauses.This is not in line with the ngs's instructions for use.The source of the applied external forces to the guide arm are unknown at this time, however it was confirmed that the user's bias operations were done while there were still external forces applied on the system, which may have been the cause of the guide arm movement.Possible sources of the external forces noted could be from the guide arm's cable becoming taut around the system or from a force applied to the handpiece from the user or patient anatomy.This event was concluded to be attributed to user error since the user did not perform the bias operation in accordance with the ngs's instructions for use.Other possible contributing factors such as cable wrapping, patient anatomy/clinical conditions may also have contributed to this event.An investigation is currently in process and if a new root cause(s) are established, a follow up mdr will be submitted to the agency.

Event Description

It was reported that during a procedure using the neocis guidance system (ngs) during implant placement, the system entered pause mode due to excessive force being recorded.To exit pause mode, the user "zeroed" the guide arm in order to continue with the procedure (per the ngs instructions for use).This "zeroing" process is known as biasing and per the ngs's instructions for use, should be performed when the guide arm is not in the vicinity of the patient.In this particular situation, the user selected the bias operation while the drill handpiece was still within the implant location and then attempted to move the guide arm after performing the biasing operation.This resulted in an unintended guide arm movement which caused the drill bit to contact the patient's gingival tissue causing a laceration.The system was then paused by the user and then moved away from the patient and the user placed 12 sutures at the contact site.No further patient complications or device issues were reported.

• Brand Name: NEOCIS INC.
• 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 FL 33127
• Manufacturer Contact: william tapia ; 530 nw 29th st; miami, FL 33127
• MDR Report Key: 13030181
• MDR Text Key: 285842793
• Report Number: 3012787974-2021-80044
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• 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): Required Intervention