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

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	07/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Log file analysis was performed.The device passed anatomical verification before proceeding with the case.Post operative scans could not be obtained therefore lost of accuracy could not be confirmed.
Event or Problem Description
After a guided procedure and post-operative assessment, it was found that the implant placement compromised the buccal wall.The surgeon removed the implant, the site was grafted, and patient was scheduled to come back another day and re do the implant placement.
Additional Manufacturer Narrative
Udi related data quality updates only.Updates based on udi/mdr data quality notification received on 13th dec 2024.

• Brand Name: NEOCIS GUIDANCE SYSTEM
• Common Device Name: DENTAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): NEOCIS, INC.; 545 nw 26th st unit 700; miami 33127
• Manufacturer (Section G): NEOCIS, INC.; 545 nw 26th st unit 700; miami FL 33127
• Manufacturer Contact: william tapia ; 545 nw 26th st unit 700; miami, FL 33127
• MDR Report Key: 18069693
• Report Number: 3012787974-2023-80074
• Device Sequence Number: 20736855
• Product Code: PLV
• UDI-Device Identifier: 00810004900004
• UDI-Public: 00810004900004
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• 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 Sex: Unknown