MAUDE Adverse Event Report: Noris Medical Ltd Tuff TT Implant; Tuff TT Dental Implant

Model Number	NM-F5108
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury

• Brand Name: Tuff TT Implant
• Common Device Name: Tuff TT 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: 50394913
• Report Number: 3011390931-2026-00258
• Device Sequence Number: 8800555
• Product Code: DZE
• UDI-Device Identifier: 07290108812480
• UDI-Public: 07290108812480
• 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: 2026
• 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): 08/23/2026

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-F5108
• Device Catalogue Number: NM-F5108
• Device Lot Number: 9001526
• 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
• Initial Report FDA Received Date: 08/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2025
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 130 LB
• Patient Race: White