MAUDE Adverse Event Report: KERR CORPORATION NX3 TRY IN GEL; TOOTH SHADE RESIN MATERIAL

Catalog Number 33656

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor's office alleged that three (3) patients had experienced a yellow tint on their veneers after placement with the nx3 product.This is the third of three (3) reports.

Manufacturer Narrative

Specific information with regard to the patient's age, gender, and weight was not provided by the doctor's office.The doctor removed the veneer and sent the veneer back to the lab for re-adjustment.The doctor will cement the veneer for the patient once the veneer is returned from the lab.Multiple attempts were made to the doctor's office on (b)(4) 2014, to obtain further information; however, the doctor's office has remained unresponsive.An 'appearance,' and 'color' tests of the returned product was performed, 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 this lot.These investigations results indicate that the incident which had occurred was not due to a product failure.

• Brand Name: NX3 TRY IN GEL
• 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: 3939324
• MDR Text Key: 16081653
• Report Number: 2024312-2014-00508
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013609
• 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: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 07/01/2014
• Device Catalogue Number: 33656
• Device Lot Number: 4648055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2013
• 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
• Treatment: NX3 LIGH CURE CLEAR
• Patient Outcome(s): Other; Required Intervention