MAXCEM ELITE
Received Aug 29, 2014
Report 2024312-2014-00602 · MDR key 4048711
Device
Product problems
- Failure To Adhere Or Bond
Patient
65 YR
- Failure of Implant
Narrative
Description of Event or Problem
A DOCTOR ALLEGED THAT A PATIENT HAD EXPERIENCED THE DEBONDING OF A VENEER THAT HAD BEEN CEMENTED WITH MAXCEM ELITE.
Additional Manufacturer Narrative
THE OFFICE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE MAXCEM ELITE WHICH HAD BEEN USED ON THE PATIENT; THEREFORE, NO LOT NUMBER OR EXPIRATION DATE WAS IDENTIFIED. THE DOCTOR REPORTED THAT THE PATIENT HAD FOUR (4) VENEERS PLACED FOR TEETH NUMBERS 7,8, 9 AND 10 AND HAD EXPERIENCED THE CHIPPING OF THE INCISIAL EDGE OF VENEERS ON TEETH #9 AND #10; HOWEVER, THE DOCTOR DOES NOT RECALL WHICH PRODUCT WAS USED TO CEMENT THE VENEERS. THE DOCTOR RE-CEMENTED THE VENEERS USING MAXCEM ELITE. ON (B)(6) 2014, THE PATIENT RETURNED TO THE DOCTOR'S OFFICE WITH TOOTH #9 DEBONDED. DURING A FOLLOW UP PHONE CALL WITH TWO (2) DOCTOR'S ASSISTANTS ON (B)(6) 2014, IT WAS NOT DEFINITIVE WHETHER OR NOT THE DOCTOR RE-CEMENTED THE TOOTH FOR THE PATIENT OR WHETHER OR NOT MAXCEM ELITE WAS USED. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION WAS PROVIDED.