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

Device Problem Insufficient Information (3190)

Patient Problem Increased Sensitivity (2065)

Event Type  Injury  

Event Description

A doctor's office alleged that approximately seven (7) patients had experienced sensitivity after placement of a restoration using the sonicfill product.This is the second of seven (7) reports.

Manufacturer Narrative

Specific patient information with regard to gender, age, and weight was not provided.The patient had experienced sensitivity and the doctor replaced the restorations using a different product, without further incident.To date, the patient has fully recovered and is doing fine.The product involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted.

Manufacturer Narrative

The doctor's office had initially alleged that for an unknown lot number of sonicfill, approximately seven (7) patients had experienced sensitivity after placement; however, specific patient or incident information could not be recalled.During a follow up phone call on 08/13/14, it was discovered that two (2) additional lot numbers 5044576 and 5091596 were also associated with the alleged incident.Although the office identified three (3) different lots associated with the sensitivity, the office could not verify which lot was used on any of the patients.A visual evaluation was performed on the returned product from the two (2) provided lots #5044576 and #5091596, 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 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: 4006810
• MDR Text Key: 4774525
• Report Number: 2024312-2014-00574
• 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: 08/04/2014

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: 08/04/2014
• Initial Date FDA Received: 08/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/10/2014
• 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
• Treatment: PRIME & BOND
• Patient Outcome(s): Other; Required Intervention