MAUDE Adverse Event Report: DENTSPLY CAULK COREX FLOW; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 60667330

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

In this event it was reported that two patients had a tooth become symptomatic after undergoing a restorative procedure with core-x flow.One patient's tooth was extracted and the other patient had root canal therapy done.

Manufacturer Narrative

Therefore, because medical intervention was required, this event is reportable per 21 cfr part 803.This report is for the second patient.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

• Brand Name: COREX FLOW
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4585172
• MDR Text Key: 5448404
• Report Number: 2515379-2015-00011
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• PMA/PMN Number: K896564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 60667330
• Device Lot Number: 140909
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability