NX3 DUAL CURE CLEAR
Received Jul 30, 2014
Report 2024312-2014-00547 · MDR key 3967659
Device
Product problems
- Failure To Adhere Or Bond
Patient
Not reported
- No Information
Narrative
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 SECOND OF TWO (2) REPORTS.
Additional Manufacturer Narrative
SPECIFIC INFORMATION WITH REGARD TO THE PATIENT'S GENDER, AGE, AND WEIGHT WAS NOT PROVIDED. THE PATIENT HAD EXPERIENCED THE DEBONDING OF A CROWN APPROXIMATELY TWO (2) WEEKS AFTER PLACEMENT. THE PATIENT RETURNED TO THE OFFICE AND 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.