BREEZE CEMENT
Received Jan 7, 2015
Report 2024312-2015-00002 · MDR key 4393574
Device
Product problems
- Failure To Adhere Or Bond
- Leak/Splash
Patient
Not reported
- Failure of Implant
Narrative
Description of Event or Problem
A DOCTOR ALLEGED THAT ONE (1) PATIENT HAD EXPERIENCED MICROLEAKAGE AND TWO (2) PATIENTS HAD EXPERIENCED THE DEBONDING OF AN ONLAY AFTER PLACEMENT WITH THE BREEZE CEMENT. THIS IS THE SECOND OF THREE (3) REPORTS.
Additional Manufacturer Narrative
SPECIFIC PATIENT INFORMATION SUCH AS GENDER, AGE, AND WEIGHT WAS NOT PROVIDED. THE PATIENT HAD EXPERIENCED THE DEBONDING OF AN ONLAY. UPON THE PATIENT'S RETURN VISIT, THE DOCTOR PREPARED THE TOOTH AND CEMENTED A CROWN. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, A CHEMICAL EVALUATION WAS PERFORMED ON A RETAINED SAMPLE FROM THE SAME LOT, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.