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

Model Number	NM-F4220
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The healthcare professional reports the implant was inserted (b)(6) 2025 in the patient's mouth.On (b)(6) 2026, implant failed was reported without reason.The device was forwarded to the manufacturer.No patient operative or post-operative complications reported.Based on the available information the exact issue could not be identified.
Additional Manufacturer Narrative
An investigation has been completed, events recognizing that a definitive root cause cannot be identified due to a wide range of missing external factors (non-design or manufacturing related), including reason of implant removal.The dhr was reviewed for lot#9000797, and no evidence was discovered to indicate that a product defect or non-conformity contributed to the issue.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.

• Brand Name: TUFF IMPLANT
• Common Device Name: TUFF 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: anna dvinska ; hataasia 8; nesher, 36888-08 ; IS 3688808
• MDR Report Key: 24746670
• Report Number: 3011390931-2026-00108
• Device Sequence Number: 21139816
• Product Code: DZE
• UDI-Device Identifier: 07290108812220
• UDI-Public: 07290108812220
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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-F4220
• Device Catalogue Number: NM-F4220
• Device Lot Number: 9000797
• 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: 03/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White