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

Model Number	DRW-1000-00
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
After a guided procedure, it was found that the implant placement was not in the location expected by the user compared to the surgical plan.A post-operative assessment with the system's log files was completed and a system accuracy check was completed.A definitive root cause for the inaccuracy reported could not be determined, there was no indication of a device malfunction based on investigation.The surgeon removed the implant and replaced it by hand.No further medical intervention was reported as a result of this issue.The handpiece is a standard 3rd party instrument used with yomi not manufactured by neocis.
Additional Manufacturer Narrative
Rationale for decision to cease reporting: given that no events have met the definition of death or serious injury during the past two (2) years and ten (10) months, and based on the evaluations from qualified medical professionals, neocis concludes that continued reporting of adverse events related to damage to bony anatomy from improper implant placement is not necessary.In addition, neocis has updated sw-0185-rc master harms list to downgrade the harm associated with damage to bony anatomy from improper implant placement from a harm of s3 serious to s2 minor.
Additional Manufacturer Narrative
Udi related data quality updates only.Updates based on udi/mdr data quality notification received on december 13, 2024.

• Brand Name: NEOCIS GUIDANCE SYSTEM
• Common Device Name: DENTAL NAVIGATION SYSTEM
• Manufacturer (Section D): NEOCIS INC.; 545 nw 26th st; unit 700; miami FL 33127
• Manufacturer (Section G): NEOCIS INC.; 545 nw 26th st; unit 700; miami FL 33127
• Manufacturer Contact: alon mozes ; 545 nw 26th st; unit 700; miami, FL 33127
• MDR Report Key: 20570931
• Report Number: 3012787974-2024-80091
• Device Sequence Number: 20859550
• Product Code: PLV
• UDI-Device Identifier: 00810004900004
• UDI-Public: 00810004900004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DRW-1000-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/22/2024; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female