MAUDE Adverse Event Report: KERR CORPORATION NX3; DENTAL CEMENT

Device Problem Component Falling (1105)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor alleged that one (1) patient had experienced the loss of a veneer from tooth #9 on two (2) separate occasions after placement with the nx3 product.

Manufacturer Narrative

Specific information with regard to the patient's age and weight was not provided by the doctor.The doctor reported that the first incident had occurred approximately five (5) months after placement.The patient had returned to the office and the veneer was re-cemented using the same product.Approximately ten (10) months after re-cementation, the veneer had debonded a second time.The patient returned to the office and the veneer was cleaned out and re-cemented using a new batch of nx3, without further incident.To date, the patient is doing fine.The product involved in the alleged incident was not returned and no lot number or catalog number was provided; therefore, no evaluation can be conducted.

• 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: 3802716
• MDR Text Key: 4527209
• Report Number: 2024312-2014-00284
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062519
• 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: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2014
• 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 SOLO PLUS; KERR SILANE PRIMER
• Patient Outcome(s): Other; Required Intervention