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

Catalog Number DMC0087

Device Problems Material Discolored (1170); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A distributor reported that a doctor alleged that a patient had experienced the cement changing colors after placement with the breeze product.

Manufacturer Narrative

It was reported that the doctor noticed that the cement was pink and continued to use the product on the patient.Upon the patient's return visit, the doctor removed the crown, cleaned and re-cemented the crown for the patient, without further incident.To date, the patient is doing fine.A visual evaluation was performed on the returned product.The color test revealed that the returned product did not meet specifications; therefore, a retained sample from the same lot was evaluated, which yielded results within specifications.A dhr review indicated that there were no deviations from the manufacturing process.The investigation results indicate that this is an isolated incident.No similar complaints have been received with regard to this lot and the material meets all other specifications.

• 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: 3872341
• MDR Text Key: 15362938
• Report Number: 2024312-2014-00467
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• 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: DMC0087
• Device Lot Number: 4920317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2014
• 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
• Patient Age: 34 YR
• Patient Weight: 65