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

Model Number	NM-F4432
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2025.On (b)(6) 2025 , loosening of implant not related to bone ingrowth was verified.According to the information, the patient is a healthy.At the event, the patient experienced: pain.Observed during the event: mobility.The device was forwarded to the manufacturer.No patient operative or post-operative complications 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: 23837539
• Report Number: 3012141159-2025-00501
• Device Sequence Number: 12029081
• Product Code: DZE
• UDI-Device Identifier: 07290108816488
• UDI-Public: 07290108816488
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/18/2025
• Report Date (Section F): 12/18/2025

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-F4432
• Device Catalogue Number: NM-F4432
• Device Lot Number: 0026702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/03/2025
• Device Age: 35 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/18/2025