NX3 DUAL CURE
Received Sep 24, 2014
Report 2024312-2014-00622 · MDR key 4115437
Device
Product problems
- Failure To Adhere Or Bond
Patient
58 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A DOCTOR'S OFFICE ALLEGED THAT TWO (2) PATIENTS HAD EXPERIENCED THE DEBONDING OF A RESTORATION WITHIN ONE (1) DAY OF PLACEMENT WITH THE NX3 DUAL CURE CLEAR PRODUCT. THIS IS THE FIRST OF TWO (2) REPORTS.
Additional Manufacturer Narrative
A FULL CROWN WAS PLACED FOR THE PATIENT ON TOOTH #7 ON (B)(6) 2014. THE PATIENT HAD EXPERIENCED THE DEBONDING OF THE CROWN THE SAME DAY (B)(6) 2014 AND REPORTED THAT SHE HAD SWALLOWED IT; HOWEVER, THE PATIENT WAS DOING FINE. THE PATIENT RETURNED TO THE DOCTOR'S OFFICE ON (B)(6) 2014 AND A TEMPORARY CROWN WAS SEATED. THE PATIENT RETURNED TO THE OFFICE AT A LATER DATE AND A NEW PERMANENT CROWN WAS SEATED. TO DATE, THE PATIENT IS DOING FINE. A PHYSICAL EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.