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

Model Number	NM-F4455
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The healthcare professional reports that the nm-f4455 lot#0025757 implant was inserted in the patient's mouth in (b)(6) 2024.The implant was removed during placement due to pterygoid soft bone.The device was forwarded to the manufacturer.A longer implant was replaced.No patient-operative or post-operative complications were reported.
Additional Manufacturer Narrative
The probability of a manufacturing or design defect that might lead to implant replacement due to a patient's anatomical defect has been nonexistent.If additional information is received that indicates the device may have caused or contributed to the event, an additional report will be submitted.
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: 19474693
• Report Number: 3011390931-2024-00280
• Device Sequence Number: 6913842
• Product Code: DZE
• UDI-Device Identifier: 07290108812398
• UDI-Public: 07290108812398
• 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): 06/06/2024

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 Model Number: NM-F4455
• Device Catalogue Number: NM-F4455
• Device Lot Number: 0025757
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2022
• 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: 82 YR
• Patient Sex: Female