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

Model Number	NMCF4211
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that nmcf4211, lot #9001322 implant lacked primary stability on tooth #20, due to low torque.The implant was removed during implant placement with no report of observable clinical symptoms.According to the information, the patient has alcohol use disorder.The device was forwarded to the manufacturer.No other medical issues were reported.

• Brand Name: TUFF UNICON IMPLANT
• Common Device Name: TUFF UNICON DENTAL IMPLANT
• Manufacturer (Section D): NORIS MEDICAL LTD; hataasia 8; nesher, 36888 08; IS 3688808
• MDR Report Key: 21967643
• Report Number: 3012141159-2025-00279
• Device Sequence Number: 18175551
• Product Code: DZE
• UDI-Device Identifier: 07290116153421
• UDI-Public: 07290116153421
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/06/2025
• Report Date (Section F): 05/06/2025

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: NMCF4211
• Device Catalogue Number: NMCF4211
• Device Lot Number: 9001322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/17/2025
• Device Age: 9 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Date Report Sent to FDA: 05/06/2025