MAUDE Adverse Event Report: PENTRON CLINICAL BREEZE SELF-ADHESIVE RESIN CEMENT; DENTAL CEMENT

Catalog Number N97E

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor's office had alleged that five (5) patients had experienced the debonding of a restoration after placement with the breeze cement.This is the fifth of five (5) reports.

Manufacturer Narrative

Patient specifics with regard to gender, age, and weight were not provided by the doctor.The doctor re-cemented the crown, without further incident.To date, the patient is doing fine.The product involved in the alleged incident was not returned; therefore, an 'adhesive strength' test was performed on a retained sample, 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 regards to this lot.

• Brand Name: BREEZE SELF-ADHESIVE RESIN 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: 3702368
• MDR Text Key: 4235736
• Report Number: 2024312-2014-00183
• 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: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: N97E
• Device Lot Number: 4963846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2013
• 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