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

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor alleged that three (3) patients had experienced the debonding of a restoration after placement with the optibond xtr and nx3 white cement products.This is the first of three (3) reports.

Manufacturer Narrative

The doctor noted that the patient was approximately (b)(6); however, information surrounding the incidents and treatment dates were not provided by the doctor.The patient had experienced the debonding of a four (4) unit bridge from tooth #2 through #5 on two (2) separate instances.The first instance occurred approximately one (1) month after placement.The patient returned to the office and the doctor re-cemented the restoration using the same products.The second instance occurred approximately six (6) months later.The patient returned to the office on (b)(6) 2014 and the doctor re-cemented the restoration using the same products.To date, the patient is doing fine.While reviewing the doctor's bonding technique, it was discovered that he had not applied the optibond xtr adhesive to the internal portion of the restorations per the directions for use.The optibond xtr product (adhesive (catalog #35108, lot #5035103) and primer (catalog # 35107 and lot #4657225)) involved in the alleged incident was not returned; therefore, a physical evaluation was performed on a retained sample, yielding results within specifications.

• 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: 3856705
• MDR Text Key: 4619404
• Report Number: 2024312-2014-00432
• 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: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• 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: 05/13/2014
• 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: NX3 WHITE CEMENT
• Patient Outcome(s): Other; Required Intervention