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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NORIS MEDICAL LTD ZYGOMATIC IMPLANT; ZYGOMATIC DENTAL IMPLANT
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NORIS MEDICAL LTD ZYGOMATIC IMPLANT; ZYGOMATIC DENTAL IMPLANT Back to Search Results
Model Number NM-F4437
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/15/2025
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 healthy.Observed during the event: infection.The device was forwarded to the manufacturer.No patient operative or post-operative complications reported.
 
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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 Key23464987
Report Number3012141159-2025-00461
Device Sequence Number10122311
Product Code DZE
UDI-Device Identifier07290108812329
UDI-Public07290108812329
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Device Explanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 11/04/2025
Report Date (Section F) 11/04/2025
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 Expiration Date06/15/2025
Device Model NumberNM-F4437
Device Catalogue NumberNM-F4437
Device Lot Number0020715
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/29/2025
Device Age55 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer11/04/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/04/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age68 YR
Patient SexFemale
Patient Weight49 KG
Date Report Sent to FDA11/04/2025
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