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

Model Number	NM-F3311
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dhr was reviewed for lot#9000775 and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.The investigation for this event has not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Our manufacturing system assures, that production and process controls are in place to ensure that batches conform to the applicable specifications before they are distributed.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
The healthcare professional reports the implant was inserted (b)(6) 2025 in the patient's mouth.On (b)(6) 2026 loss of osseointegration was reported.Observed during the event: implant fracrured/ mobiluty.The doctor said that implant failed as the temporary went through micromovement.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.
Additional Manufacturer Narrative
(updates) during the evaluation of the implant, it was found that it was not implant fracture, so the doctor incorrectly indicated the one of the reason for the implant removal.

• 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: 24601608
• Report Number: 3011390931-2026-00078
• Device Sequence Number: 8365945
• Product Code: DZE
• UDI-Device Identifier: 07290108812046
• UDI-Public: 07290108812046
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2026

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-F3311
• Device Catalogue Number: NM-F3311
• Device Lot Number: 9000775
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• 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: 24 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American