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

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor's office alleged that two (2) patients had experienced voids within their restorations after placement with sonicfill composite.This is the second of two (2) reports.

Manufacturer Narrative

Patient specific with regard to gender, age, and weight was not provided.Although the doctor provided three (3) different shades associated with the voids, he could not verify which lot was used on each patient; therefore, no lot numbers were identified.The lots involved in the alleged incidents include lot numbers 4931574, 4931579, and 4931576.The doctor could not recall patient or incident detail.To date, the patient is doing fine.The doctor drilled out the restoration and redid the procedure using the same product, without further incident.An 'extrusion' and 'void concentration' tests of the returned product was performed, 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: 3786775
• MDR Text Key: 4443626
• Report Number: 2024312-2014-00276
• 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: 04/03/2014

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 05/02/2014
• 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