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 four (4) patients had experienced black specks in their restorations after the composite had been light cured.This is the first of four (4) reports.

Manufacturer Narrative

Specific patient information with regard to gender, age, and weight was not provided.Although the doctor identified two (2) different lots associated with the black specks, the doctor could not verify which lot was used on the patient; therefore, no catalog numbers or lot numbers were identified.The lots involved in the alleged incident included lot numbers 4819837 (catalog #34922) and 4839377 (catalog #34921).The doctor drilled out the composite and replaced the restoration during the same office visit.To date, the patient is doing fine.The products involved in the alleged incident were not returned; therefore, a visual evaluation was performed on retained samples from both lots, yielding results within specifications.

• 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: 4282022
• MDR Text Key: 17217911
• Report Number: 2024312-2014-00670
• 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: 10/29/2014

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 11/26/2014
• 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