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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation for this event has not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.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
A healthcare professional reported the way they planned it the platform was 3-4mm supracrestal we had to switch to shorter implant for restorability.The device was forwarded to the manufacturer.No other medical issues were 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: 19544726
• Report Number: 3011390931-2024-00311
• Device Sequence Number: 18036121
• 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): 06/16/2024

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: 11/25/2025
• Device Model Number: NM-F4455
• Device Catalogue Number: NM-F4455
• Device Lot Number: 0021558
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2020
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White