MAUDE Adverse Event Report: PENTRON CLINICAL BREEZE CEMENT; DENTAL CEMENT

Catalog Number N97B

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced the debonding of a crown on four (4) separate occasions after placement with the breeze cement.

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.

• Brand Name: BREEZE CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): PENTRON CLINICAL; 1717 west collins avenue; orange CA 92867
• Manufacturer (Section G): PENTRON CLINICAL; 1717 west collins avenue; orange CA 92867
• Manufacturer Contact: kerri casino ; 1717 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 4122058
• MDR Text Key: 4793715
• Report Number: 2024312-2014-00624
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 12/01/2015
• Device Catalogue Number: N97B
• Device Lot Number: 5075373
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 50