BREEZE CEMENT
Received Jul 15, 2015
Report 2024312-2015-00017 · MDR key 4917366
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Sensitivity of Teeth
Narrative
Description of Event or Problem
A DOCTOR ALLEGED THAT A PATIENT EXPERIENCED SENSITIVITY AFTER BREEZE CEMENT WAS USED WITH A TITANIUM CROWN. THE CROWN WAS REMOVED. TOOTH #15 WAS EXTRACTED BECAUSE ENDODONTICS WAS CONTRAINDICATED DUE TO THE LEVEL OF BONE LOSS.
Additional Manufacturer Narrative
A DOCTOR ALLEGED THAT A PATIENT EXPERIENCED SENSITIVITY AFTER BREEZE CEMENT WAS USED WITH A TITANIUM CROWN. THE CROWN WAS REMOVED. TOOTH #15 WAS EXTRACTED BECAUSE ENDODONTICS WAS CONTRAINDICATED DUE TO THE LEVEL OF BONE LOSS. ATTEMPTS WERE MADE TO CONTACT THE DOCTOR FOR FOLLOW-UP INFORMATION ON THE PATIENT'S CURRENT CONDITION; HOWEVER NO RESPONSE WAS RECEIVED FROM THE DOCTOR. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT(S) WAS NOT RETURNED; THEREFORE, A RETAIN SAMPLE WAS EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS.