MAXCEM ELITE
Received Aug 13, 2014
Report 2024312-2014-00550 · MDR key 4006805
Device
Product problems
- Loss of or Failure to Bond
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
A DOCTOR'S OFFICE ALLEGED THAT A PATIENT HAD EXPERIENCED THE LOSS OF A VENEER ON FOUR (4) SEPARATE OCCASIONS AFTER PLACEMENT USING THE MAXCEM ELITE CLEAR AND OPTIBOND XTR PRODUCTS.
Additional Manufacturer Narrative
SPECIFIC INFORMATION WITH REGARD TO THE PATIENT'S AGE AND WEIGHT WAS NOT PROVIDED. THE OFFICE REPORTED THAT THE VENEER HELD FOR APPROXIMATELY TWO (2) MONTHS IN BETWEEN EACH DEBONDING. THE PATIENT RETURNED TO THE OFFICE AFTER EACH DEBONDING AND THE VENEER WAS CLEANED OUT AND RE-CEMENTED. ON TWO (2) OCCASIONS THE VENEER WAS SENT BACK TO THE LAB FOR CLEANING PRIOR TO RE-CEMENTATION. THE VENEER WAS RE-CEMENTED USING THE SAME PRODUCTS. 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.