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

Device Problems Material Discolored (1170); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor alleged that the shade for premise composite appeared translucent after placement for three (3) patients.This is the first of three (3) reports.

Manufacturer Narrative

Specific incident with regard to patient age, weight and gender was not provided.Although the doctor identified three (3) different shades associated with the shade discrepancy, the doctor could not verify which lot was used on each patient; therefore, no lot numbers were identified in this report.The lots involved in the alleged incidents include lot numbers 4961963, 5143048 and 5233636.It was reported that the doctor replaced the restoration for the patient.To date, the patient is doing fine.A color test was performed on the return products yielding results within specifications.A dhr review revealed that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to these lots.

• Brand Name: PREMISE 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: 4726452
• MDR Text Key: 5738438
• Report Number: 2024312-2015-00023
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032921
• 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: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• 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
• Date Manufacturer Received: 03/25/2015
• 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