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

Model Number	NM-F4447
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sinus Perforation (2277)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The probability of a manufacturing or design defect that might lead to sinus penetration due to a patient's anatomical defect has been nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
The healthcare professional reports that nm-f4447 lot#0023371 implant was inserted (b)(6) 2024 in the patient's mouth.The implant was removed during implant placement due to sinus penetration.The device was forwarded to the manufacturer.It was reported by a health professional that the result of sinus penetration was an anatomical defect of a patient that didn't allow proper torque.No patient operative or post-operative complications reported.
Additional Manufacturer Narrative
Udi related data quality updates only.

• 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: 19245545
• Report Number: 3011390931-2024-00040
• Device Sequence Number: 12608516
• Product Code: DZE
• UDI-Device Identifier: 07290108812367
• UDI-Public: 07290108812367
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2024

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: 06/09/2026
• Device Model Number: NM-F4447
• Device Catalogue Number: NM-F4447
• Device Lot Number: 0023371
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2024
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2021
• 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 Sex: Unknown