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

Model Number	NM-F4442
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that nm-f4442 lot isn't provided implant lacked primary stability.The implant was removed during implant placement with no report of observable clinical symptoms.According to the information, the patient is smoker.The device was forwarded to the manufacturer.No other medical issues were reported.
Additional Manufacturer Narrative
Lot number was not provided, therefore the device history records could not be reviewed.Should the lot number will be provided, an investigation will be completed, and a supplemental report will be submitted at the conclusion of the investigation.Additional follow-up is being performed in an attempt to obtain all missing information.

• Brand Name: ZYGOMATIC IMPLANT
• Common Device Name: ZYGOMATIC DENTAL IMPLANT
• Manufacturer (Section D): NORIS MEDICAL LTD; hataasia 8; nesher, 36888 08; IS 3688808
• Manufacturer (Section G): NORIS MEDICAL LTD; hataasia 8; nesher, 36888 08; IS 3688808
• Manufacturer Contact: elena leonova ; hataasia 8; nesher, 36888-08 ; IS 3688808
• MDR Report Key: 21216590
• Report Number: 3011390931-2025-00022
• Device Sequence Number: 8740493
• Product Code: DZE
• UDI-Device Identifier: 07290108812343
• UDI-Public: 07290108812343
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151909
• 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: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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-F4442
• Device Catalogue Number: NM-F4442
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White