MAXCEM ELITE
Received Oct 3, 2014
Report 2024312-2014-00630 · MDR key 4138006
Device
Product problems
- Failure To Adhere Or Bond
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
ALTHOUGH THE DOCTOR IDENTIFIED TWO (2) DIFFERENT LOTS ASSOCIATED WITH THE DEBONDING, THE DOCTOR COULD NOT VERIFY WHICH LOT WAS USED ON EACH OF THE PATIENTS; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 5156204 AND 5097554. SPECIFIC INFORMATION WITH REGARD TO THE PATIENT AGE AND WEIGHT WERE NOT PROVIDED. THE PATIENT HAD EXPERIENCED THE DEBONDING OF A VENEER APPROXIMATELY ONE (1) MONTH PLACEMENT. UPON THE PATIENT'S RETURN VISIT, THE DOCTOR CLEANED AND RE-CEMENTED THE VENEER, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS WERE NOT RETURNED; THEREFORE, AN ADHESIVE STRENGTH EVALUATION WAS PERFORMED ON THE RETAIN SAMPLE, 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 THESE LOTS.
Description of Event or Problem
A DOCTOR'S OFFICE ALLEGED THAT TWO (2) PATIENTS HAD EXPERIENCED A DEBONDING OF RESTORATIONS AFTER PLACEMENT WITH MAXCEM ELITE. THIS IS THE SECOND OF TWO (2) REPORTS.