MAUDE Adverse Event Report: KERR CORPORATION SONICFILL COMPOSITE; TOOTH SHADE RESIN MATERIAL

Device Problems Device Operates Differently Than Expected (2913); Material Distortion (2977)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

A doctor alleged that six (6) patients had experienced the black specks within their restorations after light curing with the sonicfill material.This is the second of six (6) reports.

Manufacturer Narrative

Although the doctor identified two (2) shades associated with the black specks, he could not verify which lot was used on each patient; therefore, no lot numbers were identified in this report.The lots involved in the alleged incidents include lot numbers 4859240 and 4874468.Specific patient information with regard to gender, age and weight was not provided.The doctor removed the sonicfill restoration and repeated the procedure during the same visit, without further incident.To date, the patient is doing fine.The product involved in the alleged incident was not returned; therefore, an appearance test of the retain sample was performed, yielding results within specifications.A dhr review revealed that there were no deviations from the manufacturing process.

• Brand Name: SONICFILL COMPOSITE
• Type of Device: TOOTH SHADE RESIN MATERIAL
• 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: 4025221
• MDR Text Key: 4877239
• Report Number: 2024312-2014-00537
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091023
• 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: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention