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

Model Number	NMCF3710
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2025.On (b)(6) 2025, loosening of implant not related to bone ingrowth was verified.According to the information, the patient is a healthy, smoker.At the event, the patient experienced: pain.Observed during the event: mobility.The device was forwarded to the manufacturer.No patient operative or post-operative complications reported.
Additional Manufacturer Narrative
The dhr was reviewed for lot#9001341 and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.To date, items of the same lot have been sold without any similar reported event during the period of review.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.

• 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
• 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: 22279250
• Report Number: 3011390931-2025-00384
• Device Sequence Number: 12524370
• Product Code: DZE
• UDI-Device Identifier: 07290116153353
• UDI-Public: 07290116153353
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K240202
• 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: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: NMCF3710
• Device Catalogue Number: NMCF3710
• Device Lot Number: 9001341
• 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: 05/28/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2024
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White