MAUDE Adverse Event Report: KERR CORPORATION NX3; DENTAL CEMENT

Catalog Number 33643

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced discoloration under their restoration after placement with nx3 dual cure product.

Manufacturer Narrative

Specific patient information with regard to age and weight was not provided.Upon the patient's return visit on (b)(6) 2014, the doctor repeated the procedure for the patient using a different shade of nx3 without further incident.To date, the patient is doing fine.A 'visual inspection' and 'color test' of the returned product were 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.

• Brand Name: NX3
• Type of Device: DENTAL CEMENT
• 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: 3767380
• MDR Text Key: 4469321
• Report Number: 2024312-2014-00268
• Device Sequence Number: 1
• Product Code: EMA
• 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: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 10/01/2015
• Device Catalogue Number: 33643
• Device Lot Number: 5005168
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2013
• 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
• Patient Outcome(s): Other; Required Intervention