MAUDE Adverse Event Report: PENTRON CLINICAL FUSIO LIQUID DENTIN; MATERIAL, TOOTH SHADE, RESIN

Catalog Number N21SC

Device Problems Failure To Adhere Or Bond (1031); Nonstandard Device (1420); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor alleged that the fusio self-adhesive flowable composite was too thick did not adhere to the floor of the restoration during procedures on five (5) patients.This is the second of five (5) reports.

Manufacturer Narrative

Specific patient information with regard to gender, age, and weight was not provided.The doctor drilled out the composite and replaced the restorations using a different product during the same office visit.To date, the patient is doing fine.The product was returned and a visual and physical evaluation was performed, yielding results within specifications.In addition, no similar complaints were received with regard to this lot.

• Brand Name: FUSIO LIQUID DENTIN
• 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: 3729810
• MDR Text Key: 4271137
• Report Number: 2024312-2014-00253
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 11/01/2014
• Device Catalogue Number: N21SC
• Device Lot Number: 4747163
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other