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

Catalog Number 33643

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced the loss of crowns from teeth #6 through #11 after placement with the nx3 dual cure clear cement.

Manufacturer Narrative

Patient specifics with regard to gender, age, and weight were not provided.The crowns were seated for three (3) days before the patient had to return to the office five (5) times for different crowns debonding.The crowns were cleaned out and re-cemented each time.The doctor reported that he had not used a bonding agent during cementation, which is required as per the nx3 directions for use.The patient returned to the office and the crown was cleaned out and re-cemented using nx3 dual cure clear as per the directions for use.To date, the patient is doing fine.The product involved in the alleged incident was not returned; therefore, a physical evaluation was performed on a retained sample, yielding results within specifications.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: 3660627
• MDR Text Key: 4348981
• Report Number: 2024312-2014-00167
• 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: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 11/01/2015
• Device Catalogue Number: 33643
• Device Lot Number: 5035073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2013
• 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