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	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that surgeon unable to get appropriate torque on implant site #4, nmcf4211, lot#9001322 implant lacked primary stability.The implant was removed during implant placement with no report of observable clinical symptoms.According to the information, the patient has hypertension.The device was forwarded to the manufacturer.No other medical issues were reported.
Additional Manufacturer Narrative
The dhr was reviewed for lot#9001322 and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.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: 21967753
• Report Number: 3011390931-2025-00311
• Device Sequence Number: 18268494
• Product Code: DZE
• UDI-Device Identifier: 07290116153421
• UDI-Public: 07290116153421
• 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): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White