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

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor alleged that black specks were present in the sonicfill composite during procedures on two (2) patients.This is the first of two (2) reports.

Manufacturer Narrative

Specific patient information with regard to gender, age and weight was not provided.Although the office identified three (3) different lots associated with the black specks, the office could not verify which lot had been used on the patient; therefore, no lot numbers were identified in this report.The lots involved in the alleged incident include lot numbers 4427237, 5077103, and 4874476.The doctor drilled out the composite and repeated the procedure during the same office visit.To date, the patient is doing fine.The products involved in the alleged incident were returned and a visual evaluation was performed on each of the lots, yielding results within specifications.In addition, a dhr review indicated 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: 3929452
• MDR Text Key: 4602120
• Report Number: 2024312-2014-00494
• 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: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2014
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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