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

Model Number	NMCF3513
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The healthcare professional reports the implant was inserted (b)(6) 2025 in the patient's mouth.On (b)(6) 2025 , loss of osseointegration was reported.According to the information, the patient is healthy.Observed during the event: bone loss, mobility.The device was forwarded to the manufacturer.No patient operative or post-operative complications 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: 21932664
• Report Number: 3012141159-2025-00274
• Device Sequence Number: 12947345
• Product Code: DZE
• UDI-Device Identifier: 07290116154435
• UDI-Public: 07290116154435
• 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): 04/30/2025
• Report Date (Section F): 04/30/2025

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: NMCF3513
• Device Catalogue Number: NMCF3513
• Device Lot Number: 9001436
• 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: 4 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Hispanic
• Patient Race: White
• Date Report Sent to FDA: 04/30/2025