MAUDE Adverse Event Report: KERR CORPORATION OPTIBOND XTR; RESIN TOOTH BONDING AGENT

Catalog Number 35108

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Event Description

A doctor alleged that two (2) patients had experienced the loss of veneers after placement using the optibond xtr and nx3 dual cure clear products.This is the second of two (2) reports.

Manufacturer Narrative

The patient had experienced the delamination of veneers from teeth #8 and #9 during placement.The doctor cut off the veneers which had partially cemented and took a new impression.The patient returned to the office and new veneers were cemented using the same products, without further incident.To date, the patient is doing fine.The product involved in the alleged incident was not returned; therefore, a physical evaluation was performed on a retained sample, yielding results within specifications.In addition, no similar complaints were received with regard to this lot.

• Brand Name: OPTIBOND XTR
• Type of Device: RESIN TOOTH BONDING AGENT
• 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: 3637125
• MDR Text Key: 3987277
• Report Number: 2024312-2014-00112
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101423
• 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: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 11/01/2014
• Device Catalogue Number: 35108
• Device Lot Number: 4739664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2013
• 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: NX3 DUAL CURE CLEAR CEMENT
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 100