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

Catalog Number 34923

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information with regard to gender, age and weight was not provided.The doctor removed the sonicfill restoration and repeated the procedure using a different product.The product involved in the alleged incident was not returned; however retain sample was tested and yielding results of meeting specifications.Retain sample met specifications.

Event Description

A doctor alleged that a patient had experienced the replacement of a sonicfill restoration due to microleakage.

• 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: mark dzendzel ; 1717 west collins avenue; orange, CA 92867 ; 7145167802
• MDR Report Key: 5125491
• MDR Text Key: 27415509
• Report Number: 2024312-2015-00081
• 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
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 09/03/2017
• Device Catalogue Number: 34923
• Device Lot Number: 5474712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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