MAUDE Adverse Event Report: PENTRON CLINICAL ALERT CONDENSABLE COMPOSITE; MATERIAL, TOOTH SHADE, RESIN

Catalog Number N15SA

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor's office alleged that three (3) patients had experienced a restoration which had crumbled apart after placement with the alert condensable composite.This is the first of three (3) reports.

Manufacturer Narrative

The office reported that while flossing the completed restoration for the patient, they realized that the composite nearest the curing light was crumbling interproximally, and the composite furthest away was not fully cured.The doctor removed and replaced the restoration during the same office visit using a different product, without further incident.A physical evaluation was performed on the returned product, yielding results within specifications.A dhr review revealed that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to this lot.

• Brand Name: ALERT CONDENSABLE COMPOSITE
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• 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 w collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 3995011
• MDR Text Key: 4778983
• Report Number: 2024312-2014-00542
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974131
• 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: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: N15SA
• Device Lot Number: 4986886
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2013
• 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
• Patient Age: 40 YR