MAUDE Adverse Event Report: NORIS MEDICAL LTD ONYX IMPLANT; ONYX DENTAL IMPLANT

Model Number	NM-G3713
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	05/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Following a patient's complaint and after an examination, doctor reported a fracture in 3 implants.This report is 1 of 3 related to this event, and 2 more reports are issued.
Additional Manufacturer Narrative
Following a thorough investigation into the complaint, no product deficiencies or manufacturing process deviations have been detected.We diligently attempted to establish communication with the dentist.While the dentist did provide some information, crucially, they have not furnished the lot numbers for the prosthetic parts or photographs of the restoration in its intraoral context.Consequently, we are unable to arrive at a definitive conclusion regarding the underlying cause of the issue.Should new or additional information become available during the course of this investigation, we will provide a follow-up report accordingly.We mistakenly sent the answer for this complaint on 21 june 2023 to the test system instead of the production account.Hence, the late reporting.We attached the approval that we sent the report to the test system.We improved our reporting process to avoid recurrence of such mistake.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: ONYX IMPLANT
• Common Device Name: ONYX DENTAL IMPLANT
• Manufacturer (Section D): NORIS MEDICAL LTD; hataasia 8; nesher, 36888 08; IS 3688808
• Manufacturer Contact: melaniya shalmiev ; 8 hataasia; nesher, 36888-08 ; IS 3688808
• MDR Report Key: 17867919
• Report Number: 3011390931-2023-00002
• Device Sequence Number: 7041680
• Product Code: DZE
• UDI-Device Identifier: 07290108813104
• UDI-Public: 07290108813104
• Combination Product (Y/N): Y
• Initial Reporter Country: IS
• PMA/510(K) Number: K140440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/01/2025
• Device Model Number: NM-G3713
• Device Catalogue Number: NM-G3713
• Device Lot Number: 0021287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/19/2024; 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female