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

Model Number	NM-F4311
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/21/2025
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 a smoker.According to the information, the patient has hypertension.Observed during the event: attachment broke off in implant.A secondary implant was plased after removal.The device was forwarded to the manufacturer.No patient operative or post-operative complications reported.
Additional Manufacturer Narrative
Lot number implant in report does not correspond part number implant and lot number abutment was not provided, therefore the device history records could not be reviewed.Should the corrrect lot number will be provided, an investigation will be completed, and a supplemental report will be submitted at the conclusion of the investigation.Additional follow-up is being performed in an attempt to obtain all missing information.

• Brand Name: TUFF TT IMPLANT
• Common Device Name: TUFF TT DENTAL IMPLANT
• 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: 23631101
• Report Number: 3011390931-2025-00510
• Device Sequence Number: 10477731
• Product Code: DZE
• UDI-Device Identifier: 07290108812251
• UDI-Public: 07290108812251
• 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: 2025
• 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): 11/24/2025

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 Model Number: NM-F4311
• Device Catalogue Number: NM-F4311
• 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: 11/06/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White