MAXCEM ELITE
Received Jul 30, 2014
Report 2024312-2014-00545 · MDR key 3967961
Device
Product problems
- Loss of or Failure to Bond
Patient
21 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A DOCTOR ALLEGED THAT A PATIENT HAD EXPERIENCED THE DEBONDING OF A VENEER APPROXIMATELY ONE (1) MONTH AFTER PLACEMENT WITH THE MAXCEM ELITE CLEAR PRODUCT.
Additional Manufacturer Narrative
MAXCEM ELITE INSTRUCTIONS FOR USE STATE: "FOR VENEER CEMENTATION USING MAXCEM ELITE, ADHESIVE APPLICATION ON TOOTH PREP IS REQUIRED." THE DOCTOR REPORTED THAT AN ADHESIVE HAD NOT BEEN APPLIED TO THE TOOTH PRIOR TO INITIAL CEMENTATION. THE PATIENT HAD RETURNED TO THE OFFICE ON (B)(4) 2014 AND THE VENEER WAS CLEANED OUT AND RE-CEMENTED USING MAXCEM ELITE ALONG WITH AN ADHESIVE APPLICATION. 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.