MAUDE Adverse Event Report: KERR CORPORATION SILANE PRIMER; RESIN TOOTH BONDING AGENT

Catalog Number 23448

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

A doctor alleged that approximately ten (10) patients had experienced the debonding of crowns after placement using silane primer, nx3 dual cure clear, and optibond all-in-one products.This is the second of ten (10) reports.

Manufacturer Narrative

Patient information with regard to age, gender, and weight was not provided.The doctor cleaned the posterior crown and re-cemented the crown for the patient using a different product, without further incident.To date, the patient is doing fine.The returned product is expired; therefore, no evaluation was conducted.The dhr review revealed that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to this lot.

• Brand Name: SILANE PRIMER
• 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: 3679956
• MDR Text Key: 4237212
• Report Number: 2024312-2014-00151
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954708
• 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: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 10/01/2013
• Device Catalogue Number: 23448
• Device Lot Number: 3576220
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2010
• 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; OPTIBOND ALL-IN-ONE
• Patient Outcome(s): Other; Required Intervention