TUFF TT IMPLANT
Report
- Report Number
- 3011390931-2024-00604
- Event Type
- Injury
- Date Received
- August 15, 2024
- Date of Event
- June 27, 2024
- Report Date
- August 14, 2024
- Manufacturer
- NORIS MEDICAL LTD
- Product Code
- DZE
- UDI-DI
- 07290108812596
- PMA / PMN Number
- K140440
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
UDI RELATED DATA QUALITY UPDATES ONLY.
THE DHR WAS REVIEWED FOR LOT#9000310 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.
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F6108 LOT#9000310 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #14. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1163255 | TUFF TT IMPLANT | TUFF TT DENTAL IMPLANT | DZE | NORIS MEDICAL LTD | NM-F6108 | 9000310 | 07290108812596 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |