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

Catalog Number 33643

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Event Description

A doctor alleged that two (2) patients had experienced the loss of veneers after placement using the nx3 dual cure clear and optibond xtr products.This is the first of two (2) reports.

Manufacturer Narrative

The doctor placed veneers for the patient on teeth #22 through #26 on (b)(6) 2013.The patient returned on (b)(6) 2013 after three (3) of the veneers had delaminated.The doctor re-seated the restorations using the same products.The patient returned on (b)(6) 2013 after four (4) veneers from teeth #23 through #26 had delaminated.The doctor prepared the teeth for full crowns.The patient returned to the office and the full crowns were cemented using the same products, without further incident.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: 3637087
• MDR Text Key: 4180024
• Report Number: 2024312-2014-00109
• 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: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 09/01/2015
• Device Catalogue Number: 33643
• Device Lot Number: 4997433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2013
• 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 XTR
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 77