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

Catalog Number 35106

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor alleged that thirteen (13) patients had experienced the debonding of a crown approximately three (3) to six (6) months after placement with the optibond xtr and nx3 cement products.Of these thirteen (13) patients, several had experienced the debonding of a crown a second time; however, no specific patient or incident information was provided.This is the twelfth of thirteen (13) reports.

Manufacturer Narrative

Specific patient information with regard to gender, age, and weight was not provided.The doctor either cemented a new crown or re-cemented the existing debonded crown for the patient using either the same products or different products.To date, the patient is doing fine.The products involved in the alleged incident were not returned and no lot numbers were provided; therefore, no 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: 3849908
• MDR Text Key: 4409152
• Report Number: 2024312-2014-00452
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 35106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2014
• 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 CEMENT
• Patient Outcome(s): Other; Required Intervention