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 08/23/2012

Event Type  Injury  

Event Description

A doctor alleged that multiple patients had experienced their composite washing out after placement with sonicfill.This is the second of two (2) reports.

Manufacturer Narrative

Although the doctor identified seven (7) different lots associated with the composite washing out, the office could not verify which lot had been used on each of the patients; therefore, no lot numbers were identified in section d-4 of this report.The lots involved in the alleged incident include lot numbers 4584057, 4651825, 4720951, 4427269, 4758466, 4758884, and 4678959.The doctor could not recall specific patients' detail.The doctor had to drill out the restorations for each of the patients and repeated the procedure for each of the patients.To date, the patients are doing fine.An evaluation is anticipated but has not yet begun.

Manufacturer Narrative

The products were not returned; therefore, a 'depth of cure' test of the retain samples for lots 4584057, 4651825, 4720951, 4427269, 4761703, 4734552, and 4678959 were evaluated, yielding results within specifications.A dhr review revealed that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to these lots.

• 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: 3547019
• MDR Text Key: 4114321
• Report Number: 2024312-2013-00692
• 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: 12/04/2013

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: 12/04/2013
• Initial Date FDA Received: 01/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2012
• 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