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

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The patient sought further treatment with an oral surgeon and an implant procedure was completed.The permanent crowns will be placed at a later date; however, the appointment has not yet been made.To date, the patient is doing fine at this time.

Event Description

A doctor's office alleged that two (2) patients had experienced marginal leakage underneath restorations approximately four (4) to six (6) years after placement with the breeze self-adhesive resin cement.This is the second of two (2) reports.

Manufacturer Narrative

Patient specifics with regard to age and weight were not provided by the doctor.The office alleged that the patient had experienced marginal leakage which led to decay underneath a three (3) unit bridge for tooth numbers 29, 30, and 31 approximately four (4) years after placement.It was reported that the patient may require an implant, and will be returning to the office for further consultation; however, the date and time was not provided.The office reported that they would directly contact pentron regarding any further patient information updates.An update will be provided if any new information becomes available.The product was not returned and no lot number or catalog number was provided; therefore, no evaluation can be conducted.

• 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: 3836899
• MDR Text Key: 12153699
• Report Number: 2024312-2014-00298
• 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,Followup
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2014
• 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