NX3 DUAL CURE CLEAR
Received Jul 30, 2014
Report 2024312-2014-00546 · MDR key 3967645
Device
Product problems
- Failure To Adhere Or Bond
Patient
47 YR
- No Information
Narrative
Additional Manufacturer Narrative
THE INITIAL CROWN CEMENTATION PROCEDURE OCCURRED ON (B)(6) 2014. THE PATIENT HAD EXPERIENCED THE DEBONDING OF THE CROWN AND RETURNED TO THE OFFICE ON (B)(6) 2014. THE DOCTOR CLEANED OUT THE CROWN AND RE-CEMENTED IT USING THE SAME PRODUCTS, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.
Description of Event or Problem
A DOCTOR'S OFFICE ALLEGED THAT TWO (2) PATIENTS HAD EXPERIENCED THE DEBONDING OF A CROWN AFTER PLACEMENT WITH THE NX3 DUAL CURE CLEAR AND OPTIBOND XTR PRODUCTS. THIS IS THE FIRST OF TWO (2) REPORTS.