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

Catalog Number 31513

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Sensitivity of Teeth (2427)

Event Type  Injury  

Event Description

A doctor's office alleged that multiple patients had experienced debonding of restorations, marginal leakage or sensitivity 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 re-did the restorations for the patients, without further incident.To date, the patients are doing fine.The product was not returned; therefore, no evaluations were conducted.

• 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: 4048735
• MDR Text Key: 4813580
• Report Number: 2024312-2014-00603
• 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: 08/08/2014

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 Catalogue Number: 31513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2014
• Initial Date FDA Received: 08/29/2014
• 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
• Patient Outcome(s): Other; Required Intervention