MAUDE Adverse Event Report: KERR CORPORATION NX3; DENTAL CEMENT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor alleged that ten (10) patients had experienced sensitivity after placement using the nx3 cement and the optibond xtr products.This is the tenth of ten (10) reports.

Manufacturer Narrative

Patient specifics with regard to gender, age, and weight were not provided by the doctor.Specific patient or incident details could not be recalled by the doctor.The doctor prescribed antibiotics and pain killers for the patient and/or cut off the crown, applied eugenol, made a new crown and cemented it using the same products, without further incident.To date, the patient is doing fine.The product was not returned and no lot number was provided; therefore, no evaluations 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: 3600294
• MDR Text Key: 21490875
• Report Number: 2024312-2014-00042
• 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: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• 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: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2012
• 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