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

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 06/01/2013

Event Type  Injury  

Event Description

A doctor alleged that three (3) patients had experienced voids in their restorations after placement with the sonicfill composite.This is the second of three (3) reports.

Manufacturer Narrative

Patient specifics with regard to age, gender and weight was not provided by the doctor.Upon the patient's returned visit for a routine checkup, an x-ray was taken.The doctor noticed that there were voids either at the interproximal or at the margin of the tooth.The doctor re-did the restoration for the patient using a different product, without further incident.To date, the patient is doing fine.The product was not returned and no lot number was provided; therefore, no evaluation can be conducted.

Manufacturer Narrative

Although the doctor identified two (2) different shades associated with the voids, the doctor could not verify which lot was used on each patient; therefore, no numbers were identified in this report.The shades involved in the alleged incidents include 34921 and 34922.

• 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: 3576983
• MDR Text Key: 4080132
• Report Number: 2024312-2014-00005
• 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,Followup
• Report Date: 01/03/2014

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: 01/03/2013
• Initial Date FDA Received: 01/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: No
• 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