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

Catalog Number 34923

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

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor's office alleged that black specks were present in the sonicfill composite after light curing restorations for multiple patients.

Manufacturer Narrative

Specific patient information with regard to the exact number affected, ages, genders, and weights were not provided.The doctor drilled out the area where the specks were present and refilled the spot with more sonicfill during the same office visit for each of the patients.To date, each of the patients are doing fine.The product involved in the alleged incidents was not returned; therefore, a visual evaluation was performed on a retained sample, yielding results within specifications.A dhr review indicated that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to this lot.

• 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: 3736839
• MDR Text Key: 4312673
• Report Number: 2024312-2014-00263
• 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: 03/18/2014

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
• Device Expiration Date: 07/01/2015
• Device Catalogue Number: 34923
• Device Lot Number: 4952732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2013
• 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