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

Model Number	NM-G4211
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2024.On (b)(6) 2024 , loosening of implant not related to bone ingrowth was verified.According to the information, the patient is healthy.Observed during the event: infection, mobility.The device was forwarded to the manufacturer.No patient operative or post-operative complications reported.

• Brand Name: ONYX IMPLANT
• Common Device Name: ONYX DENTAL IMPLANT
• Manufacturer (Section D): NORIS MEDICAL LTD; hataasia 8; nesher, 36888 08; IS 3688808
• MDR Report Key: 21373524
• Report Number: 3012141159-2025-00007
• Device Sequence Number: 19772721
• Product Code: DZE
• UDI-Device Identifier: 07290108813159
• UDI-Public: 07290108813159
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/13/2025
• Report Date (Section F): 02/13/2025

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
• Device Expiration Date: 07/20/2025
• Device Model Number: NM-G4211
• Device Catalogue Number: NM-G4211
• Device Lot Number: 9000307
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/22/2025
• Device Age: 50 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/13/2025