BREEZE CEMENT
Received Sep 26, 2014
Report 2024312-2014-00624 · MDR key 4122058
Device
Product problems
- Loss of or Failure to Bond
Patient
65 YR
- Failure of Implant
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT RETURNED TO THE OFFICE AND THE DOCTOR CLEANED OUT AND RE-CEMENTED THE CROWN USING THE SAME BREEZE SYRINGE THE FIRST THREE (3) TIMES THE CROWN HAD DEBONDED. ON THE PATIENT'S FOURTH RETURN VISIT, THE DOCTOR RE-CEMENTED THE CROWN USING A NEW SYRINGE OF BREEZE PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT ALLEGED IN THIS INCIDENT WAS RETURNED AND AN 'ADHESIVE STRENGTH' AND 'GEL/SET TIME' WERE PERFORMED, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS.
Description of Event or Problem
A DOCTOR ALLEGED THAT A PATIENT HAD EXPERIENCED THE DEBONDING OF A CROWN ON FOUR (4) SEPARATE OCCASIONS AFTER PLACEMENT WITH THE BREEZE CEMENT.