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

Model Number	NM-F4435
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that nm-f4435 lot#0028417 implant lacked primary stability.The implant was removed during implant placement with no report of observable clinical symptoms.The device was forwarded to the manufacturer.No other medical issues were reported.

• Brand Name: ZYGOMATIC IMPLANT
• Common Device Name: ZYGOMATIC DENTAL IMPLANT
• Manufacturer (Section D): NORIS MEDICAL LTD; hataasia 8; nesher, 36888 08; IS 3688808
• MDR Report Key: 21535185
• Report Number: 3012141159-2025-00096
• Device Sequence Number: 20767346
• Product Code: DZE
• UDI-Device Identifier: 07290108812312
• UDI-Public: 07290108812312
• 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): 06/03/2025
• Report Date (Section F): 03/06/2025

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 Model Number: NM-F4435
• Device Catalogue Number: NM-F4435
• Device Lot Number: 0028417
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2025
• Device Age: 16 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2025
• 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: 03/06/2025