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

Catalog Number N97B

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 11/12/2014

Event Type  Injury  

Event Description

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 first of three (3) reports.

Manufacturer Narrative

Specific patient information such as age and weight was not provided.The patient reported in (b)(6) 2014 that two (2) of the onlays which were placed in (b)(6) of 2014 had felt loose.Upon removal, the dentist reported that the breeze cement had not set and the patient had experienced microleakage and tooth decay.The doctor placed a zoe filling on one (1) tooth, and referred the patient to an endodontist for the second tooth.A root canal was performed by the endodontist for the second tooth.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.

• 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: 4393584
• MDR Text Key: 19718840
• Report Number: 2024312-2015-00001
• 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: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: N97B
• Device Lot Number: 5209830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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