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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Sensitivity of Teeth (2427)

Event Type  Injury  

Event Description

A doctor alleged that one hundred and twenty (120) patients had experienced sensitivity after restorations were placed using the optibond xtr product.This is the fifty-fourth of one hundred and twenty (120) reports.

Manufacturer Narrative

Specific patient information with regard to gender, age, and weight was not provided.The doctor reported that the patient had contacted the office within approximately three (3) days of placement reporting sensitivity issues.The doctor had the patient return to the office and took an x-ray; however, no issues with the restoration were noted.The doctor requested that the patient wait 2-3 weeks to see if the sensitivity would subside; however, after waiting the requested time, the sensitivity was still present.The doctor had the patient return to the office and replaced the patient's restorations.No treatment dates were provided.The doctor reported that the sensitivity has been reduced; however, the patient is still experiencing some sensitivity.The optibond xtr product (adhesive (catalog #35108, lot #4674868) and primer (catalog # 35107 and lot #4657224)) involved in the alleged incident was not returned; therefore, a visual evaluation was performed on a retained sample, yielding results within specifications.A dhr review indicated that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to this lot.

Manufacturer Narrative

It was discovered on (b)(6) 2014 that the doctor had not refrigerated the optibond xtr product, which is required as per the directions for use.It was initially reported that the product involved in the alleged incident was not returned and evaluations were performed on a retained sample; however, the optibond xtr product (adhesive (catalog #35108, lot #4674868 and primer (catalog # 35107 and lot #4657224)) involved in the alleged incident had been returned and the visual evaluation was performed on the returned sample, which yielded results within specifications.A dhr review indicated that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to these lots.

• 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: 3833267
• MDR Text Key: 4503463
• Report Number: 2024312-2014-00352
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: (B)(4); SONICFILL
• Patient Outcome(s): Other; Required Intervention