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

Model Number	NM-F3311
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number was not provided, therefore the device history records could not be reviewed.Should the 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.
Event or Problem Description
The healthcare professional reports the implant was inserted (b)(6) 2023 in the patient's mouth.On (b)(6) 2024, loss of osseointegration was reported.According to the information, the patient has hypertension.Observed during the event: bone loss, mobility.The device was forwarded to the manufacturer.No patient operative or post-operative complications reported.
Additional Manufacturer Narrative
Udi related data quality updates only.

• 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: elena leonova ; hataasia 8; nesher, 36888-08 ; IS 3688808
• MDR Report Key: 19604234
• Report Number: 3011390931-2024-00367
• Device Sequence Number: 7326687
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 06/24/2025
• 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 Sex: Unknown