MAUDE Adverse Event Report: KERR CORPORATION NX3; DENTAL CEMENT

Catalog Number 33643

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Therapeutic Response, Increased (2272)

Event Type  Injury  

Event Description

A doctor alleged that three (3) patients had experienced the debonding of restorations after placement using the nx3 cement and the optibond xtr products.This is the third of three (3) reports.

Manufacturer Narrative

Although the doctor identified four (4) different lots associated with the debonding, she could not verify which lot was used on each patient.The lots involved in the alleged incidents include lot numbers 4813434, 4855372, 4872984 and 4950258.The patient had experienced a debonding of a crown; however, the doctor could not recall specific patient or incident details.To date, the patient is doing fine.The products alleged in this incident was not returned; therefore, an 'adhesive strength' test of the retain samples were evaluated, yielding results within specifications.A dhr review revealed that there were no deviations in the manufacturing process.In addition, no similar complaints were received with regard to these lots.

• Brand Name: NX3
• 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: 3680024
• MDR Text Key: 4293029
• Report Number: 2024312-2014-00163
• 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 Catalogue Number: 33643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• 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 XTR
• Patient Outcome(s): Other; Required Intervention