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

Model Number	NM-F4310
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/26/2024
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 clinician reports the implant was inserted (b)(6) 2024.On (b)(6) 2024, loosening of implant not related to bone ingrowth was verified.According to the information, the patient has hypertension.At the event, the patient experienced: pain.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 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: elena leonova ; hataasia 8; nesher, 36888-08 ; IS 3688808
• MDR Report Key: 19604268
• Report Number: 3011390931-2024-00365
• Device Sequence Number: 7279656
• 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: 2024
• 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-F4310
• Device Catalogue Number: NM-F4310
• 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 Age: 69 YR
• Patient Sex: Unknown