MAUDE Adverse Event Report: KERR CORPORATION NX3; DENTAL CEMENT

Catalog Number 33643

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  Injury  

Event Description

A doctor alleged that one (1) patient had experienced the debonding of veneers from tooth #7, #8, #9, and #10 on three (3) separate occasions approximately two (2) days after placement with the nx3 dual cure clear and optibond xtr products.

Manufacturer Narrative

The doctor reported that the patient returned to the office after the first two (2) debondings and he had cleaned out and re-cemented the veneers using the same products on both occasions.On the third debonding, he made a new impression and new veneers were made.Specific patient information with regard to treatment dates was not provided.The new veneers will be cemented on (b)(6) 2014.An update will be provided if any new patient information becomes available.To date, the patient is doing fine.The product involved in the alleged incident was not returned and no lot 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: 3881826
• MDR Text Key: 4543662
• Report Number: 2024312-2014-00468
• 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: 05/23/2014

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 Catalogue Number: 33643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2014
• Initial Date FDA Received: 06/18/2014
• 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
• Patient Age: 27 YR