InjuryEMA
CEMENT-IT
Received Aug 25, 2014
Report 2024312-2014-00592 · MDR key 4034987
Device
Generic name
Dental Cement
Manufacturer
Pentron ClinicalProduct problems
- Failure To Adhere Or Bond
- Device Operates Differently Than Expected
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
A DOCTOR'S OFFICE ALLEGED THAT A PATIENT HAD EXPERIENCED THE DEBONDING OF RESTORATION AFTER PLACEMENT WITH CEMENT IT.
Additional Manufacturer Narrative
SPECIFIC PATIENT INFORMATION WITH REGARD TO AGE AND WEIGHT WAS NOT PROVIDED. IT WAS REPORTED THE PATIENT HAD HER BRIDGE RE-CEMENTED USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT ALLEGED IN THIS INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.