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

Model Number	NM-F3311
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2022.On (b)(6) 2026 the implant was removed.Observed during the event: implant fracture because internal screw broken and threads messed up.The device was forwarded to the manufacturer.The malfunction did not cause or contribute to a death or serious injury.No patient operative or post-operative complications reported.

• Brand Name: TUFF IMPLANT
• Common Device Name: TUFF DENTAL IMPLANT
• Manufacturer (Section D): NORIS MEDICAL LTD; hataasia 8; nesher, 36888 08; IS 3688808
• MDR Report Key: 24723781
• Report Number: 3012141159-2026-00103
• Device Sequence Number: 10133304
• Product Code: DZE
• UDI-Device Identifier: 07290108812046
• UDI-Public: 07290108812046
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/29/2026
• Report Date (Section F): 03/29/2026

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 Expiration Date: 02/23/2025
• Device Model Number: NM-F3311
• Device Catalogue Number: NM-F3311
• Device Lot Number: 9000204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/18/2026
• Device Age: 6 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/29/2026