MAUDE Adverse Event Report: KERR CORPORATION HERCULITE ULTRA; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 34347

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor's office alleged that two (2) patients had experienced the loss of a restoration after placement with the herculite ultra composite.This is the second of two (2) reports.

Manufacturer Narrative

Specific information with regard to the patient gender, age, and weight was not provided.The patient returned to the office and the procedure was repeated using herculite ultra.To date, patient is doing fine.A ' depth of cure' test of the returned product was performed, 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 these lots.

• Brand Name: HERCULITE ULTRA
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): KERR CORPORATION; 1717 west collins avenue; orange CA 92867
• Manufacturer (Section G): KERR CORPORATION; 1717 west collins avenue; orange CA 92867
• Manufacturer Contact: kerri casino ; 1717 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 3767406
• MDR Text Key: 20658440
• Report Number: 2024312-2014-00267
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082671
• 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: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 09/01/2015
• Device Catalogue Number: 34347
• Device Lot Number: 4716714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2012
• 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