MAUDE Adverse Event Report: KERR CORPORATION NX3 DUAL CURE; DENTAL CEMENT

Device Problem Material Discolored (1170)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor alleged that multiple patients had experienced the discoloration of a restoration after cementation with the nx3 dual cure cement.

Manufacturer Narrative

Specific patient information with regard to genders, ages, and weights were not provided.The office did not provide an exact number of patients affected.The office did not provide a lot number or catalog number for the product used; therefore, no information could be provided.On (b)(6) 2014, kerr was notified that the office of (b)(6) had experienced issues with the nx3 dual cure product.No further information was supplied at that time.Multiple attempts were made to gather further information; however, the complainant did not respond.On (b)(6) 2014, kerr was notified that the office had reported that multiple patients had experienced the discoloration of a restoration.No further information was supplied at that time.Multiple attempts were made to gather further information; however, the complainant did not respond.On (b)(6) 2014, it was discovered by a kerr representative that the doctor had repeated the restoration procedures for each of the patients.No further information was provided by the office.Multiple attempts were made by kerr corporation to contact the complainant in order to obtain further patient and incident information; however, the complainant has provided only limited information and has remained unresponsive to further requests for information.An update will be provided if any new information becomes available.The product involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted.

• Brand Name: NX3 DUAL CURE
• 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: 3953066
• MDR Text Key: 15105770
• Report Number: 2024312-2014-00528
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K062519
• 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: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: OPTIBOND SOLO PLUS
• Patient Outcome(s): Other; Required Intervention