TUFF UNICON IMPLANT
Report
- Report Number
- 3011390931-2025-00453
- Event Type
- Injury
- Date Received
- September 11, 2025
- Date of Event
- August 5, 2025
- Report Date
- September 11, 2025
- Manufacturer
- NORIS MEDICAL LTD
- Product Code
- DZE
- UDI-DI
- 07290116153377
- PMA / PMN Number
- K240202
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THE DHR WAS REVIEWED FOR LOT#9001398 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.
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 HAS BRUXISM. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. OBSERVED DURING THE EVENT: BONE LOSS/MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2541759 | TUFF UNICON IMPLANT | TUFF UNICON DENTAL IMPLANT | DZE | NORIS MEDICAL LTD | NMCF3713 | 9001398 | 07290116153377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male |