MAXCEM ELITE
Received Aug 18, 2014
Report 2024312-2014-00587 · MDR key 4017428
Device
Product problems
- Loss of or Failure to Bond
- Material Integrity Problem
Patient
82 YR
- No Code Available
Narrative
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 IN THIS REPORT. THE DOCTOR REPORTED THAT IN (B)(6) 2014, THE BRIDGE HAD DEBONDED DURING A ROOT CANAL PROCEDURE WHICH WAS BEING COMPLETED THROUGH THE RESTORATION. THE PATIENT RETURNED IN (B)(6) 2014 FOR RE-CEMENTATION OF THE BRIDGE. THE DOCTOR RE-CEMENTED THE RESTORATION USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. 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.
Description of Event or Problem
A DOCTOR ALLEGED THAT A PATIENT HAD EXPERIENCED THE DEBONDING OF A BRIDGE THAT HAD BEEN CEMENTED WITH MAXCEM ELITE.