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

Catalog Number 31513

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor's office alleged that multiple patients had experienced debonding of restorations after placement with optibond solo plus; however, specific incident details could not be recalled.

Manufacturer Narrative

Specific number of patients and patients' information with regard to age, gender, and weight was not provided.The doctor's office redid all the restorations for each of the patients, without further incident.To date, the patients are doing fine.The product was received in a condition which made analysis impossible.Therefore, an 'adhesive strength' test of the retain sample was evaluated, yielding results within specifications.A dhr review revealed that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regards to this lot.

• Brand Name: OPTIBOND SOLO PLUS
• 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: 3967307
• MDR Text Key: 4630670
• Report Number: 2024312-2014-00502
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991808
• 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: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 07/02/2014
• Device Catalogue Number: 31513
• Device Lot Number: 5085064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2014
• 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: BUILD IT; VISCOSTAT; ESTHEX
• Patient Outcome(s): Other; Required Intervention