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

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor's office alleged that the sonicfill composite material did not light cure and had shown signs of wearing shortly after placement on multiple patients.

Manufacturer Narrative

Specific patient information with regard to the exact number affected, genders, ages and weights were not provided.Although the office identified seven (7) different lots associated with the composite not curing or showing signs of wear, the office could not verify which lot had been used on each patient; therefore, no lot numbers were identified.The lots involved in the alleged incident include one (1) unknown lot number, and lot numbers 4874834, 4926315, 4948133, 4953972, 4978854, and 4874828.The restorations were removed and replaced using a different product for each of the patients.To date, each of the patients are doing fine.An evaluation for each of the provided lot numbers is anticipated, but has not yet begun.

Manufacturer Narrative

The lot number which was previously listed as "unknown" was revealed to be lot number 4948134.The product was not returned for lot numbers 4874828, 4874834, and 4926315; therefore, a visual and physical evaluation was performed on retained samples, yielding results within specifications.In addition, no similar complaints were reported with regard to these lots.The product was returned for lot numbers 4948134, 4948133, 4953972, and 4978854, and a visual and physical evaluation was performed, yielding results within specifications.In addition, no similar complaints were reported 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: 3558327
• MDR Text Key: 4077381
• Report Number: 2024312-2014-00007
• 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: 12/10/2013

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2013
• Initial Date FDA Received: 01/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• 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