MAXCEM ELITE
Received Aug 15, 2014
Report 2024312-2014-00583 · MDR key 4013080
Device
Generic name
Cement, Dental
Manufacturer
Kerr CorporationProduct problems
- Loss of or Failure to Bond
Patient
74 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 CATALOG NUMBER, LOT NUMBER, OR EXPIRATION DATE WAS IDENTIFIED IN THIS REPORT. THE BRIDGE WAS INITIALLY PLACED ON (B)(6) 2010. THE PATIENT RETURNED TO THE DOCTOR'S OFFICE ON (B)(6) 2014 WITH THE DEBONDED BRIDGE; THE DOCTOR CLEANED IT OUT AND RE-CEMENTED IT. 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'S OFFICE ALLEGED THAT MULTIPLE PATIENTS HAD EXPERIENCED THE DEBONDING OF A CROWN AFTER PLACEMENT WITH THE MAXCEM ELITE CLEAR; HOWEVER, SPECIFIC INCIDENT INFORMATION COULD ONLY BE RECALLED FOR SEVEN (7) PATIENTS. THIS IS THE SIXTH OF EIGHT (8) REPORTS.