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

Catalog Number 33643

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

A doctor's office alleged that two (2) patients had experienced the debonding of a restoration within one (1) day of placement with the nx3 dual cure clear product.This is the first of two (2) reports.

Manufacturer Narrative

A full crown was placed for the patient on tooth #7 on (b)(6) 2014.The patient had experienced the debonding of the crown the same day (b)(6) 2014 and reported that she had swallowed it; however, the patient was doing fine.The patient returned to the doctor's office on (b)(6) 2014 and a temporary crown was seated.The patient returned to the office at a later date and a new permanent crown was seated.To date, the patient is doing fine.A physical evaluation was performed on the returned product, yielding results within specifications.A dhr review indicated 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
• 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: 4115437
• MDR Text Key: 4837056
• Report Number: 2024312-2014-00622
• 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: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 04/01/2016
• Device Catalogue Number: 33643
• Device Lot Number: 5153126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2014
• 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: KERR SILANE PRIMER
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73