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

Device Problems Loss of or Failure to Bond (1068); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 08/12/2014

Event Type  Injury  

Event Description

A doctor's office alleged that a patient had experienced the debonding of a composite restoration immediately after placement using the optibond xtr.

Manufacturer Narrative

It was discovered that the optibond xtr product used by the office was expired.The doctor cleaned out the cavity, applied a different bonding agent, and placed new composite during the same office visit, without further incident.To date, the patient is doing fine.The optibond xtr (adhesive (catalog #35108, lot #4468395) and primer (catalog #35107, lot #4447812)) product involved in the alleged incident had expired on (b)(6) 2014; therefore, no further evaluation can be conducted.

• 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: 4041543
• MDR Text Key: 4901613
• Report Number: 2024312-2014-00595
• 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: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• 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: 08/13/2014
• 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: PREMISE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 73