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

Catalog Number 23448

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

A doctor's office alleged that two (2) patients had experienced the debonding of a restoration within one (1) day of placement with the silane primer product.This is the first of two (2) reports.

Manufacturer Narrative

A full crown was placed for the patient on tooth #7 on (b)(6) 2014.The patient had experienced the debonding of the crown the same day (b)(6) 2014 and reported that she had swallowed it; however, the patient was doing fine.The patient returned to the doctor's office on (b)(6) 2014 and a temporary crown was seated.The patient returned to the office at a later date and a new permanent crown was seated.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 from the same lot, yielding results within specifications.In addition, no similar complaints were received with regard to this lot.

• Brand Name: SILANE PRIMER
• Type of Device: TOOTH BONDING RESIN
• 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: 4115498
• MDR Text Key: 4704335
• Report Number: 2024312-2014-00645
• 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: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 01/01/2015
• Device Catalogue Number: 23448
• Device Lot Number: 4465271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2012
• 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: 58 YR
• Patient Weight: 73