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

Catalog Number 34348

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor alleged that the herculite ultra composite was radiolucent on x-rays for four (4) patients.This is the third of four (4) reports.

Manufacturer Narrative

Specific patient information with regard to gender, age, and weight was not provided.It was reported that the doctor completed the restoration and took an x-ray for insurance purposes.On the x-ray, the doctor discovered that a radiolucent composite restoration.The doctor drilled out and replaced the restoration for the patient.To date, the patient is doing fine.An evaluation is anticipated but has not yet begun.

Manufacturer Narrative

The product involved in the alleged incident was not returned; therefore, a physical evaluation was performed on a retained sample from the same lot, yielding results within specification.A dhr review indicated that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to this lot.

• 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: 4139764
• MDR Text Key: 4911701
• Report Number: 2024312-2014-00627
• 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,Followup
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 34348
• Device Lot Number: 4605473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2012
• 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