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

Catalog Number 34922

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor alleged that approximately seven (7) patients had experienced their restorations not fully polymerizing after placement with the sonicfill product.This is the fourth of seven (7) reports.

Manufacturer Narrative

Specific patient information with regard to gender, age and weight was not provided.The doctor removed the sonicfill restoration and repeated the procedure during the same visit, without further incident.To date, the patient is doing fine.A depth of cure and curing test per tip were performed on the returned device, yielding results within specifications.A dhr review revealed that there were no deviations within the manufacturing process.In addition, no similar complaints were received with regards 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: 4042689
• MDR Text Key: 19921293
• Report Number: 2024312-2014-00568
• 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: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: 34922
• Device Lot Number: 5113263
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2014
• 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