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

Catalog Number 33643

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor's office alleged that approximately ten (10) patients had experienced the debonding of crowns after placement using the nx3 dual cure clear, optibond all-in-one, and silane primer products.This is the eighth of ten (10) reports.

Manufacturer Narrative

Patient information with regard to age, gender, and weight was not provided.The doctor cleaned the posterior crown and re-cemented the crown for the patient using a different product, without further incident.To date, the patient is doing fine.An 'adhesive strength' test of the returned product was evaluated, yielding results within specification.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 DUAL CURE CLEAR
• 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: 3679792
• MDR Text Key: 15113486
• Report Number: 2024312-2014-00137
• 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: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 07/01/2015
• Device Catalogue Number: 33643
• Device Lot Number: 4947517
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2013
• 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: OPTIBOND ALL-IN-ONE; SILANE PRIMER
• Patient Outcome(s): Other; Required Intervention