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

Catalog Number 35106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Patient specifics with regard to age and weight were not provided by the doctor.Endodontic treatment was required to resolve the sensitivity symptoms.The doctor identified two (2) different lots (5295307 and 5558644) associated with the sensitivity, but the doctor could not verify which lot was used on any of the patients.The product involved in the alleged incident(s) was not returned; therefore, retain samples of lots (5295307 and 5558644) were evaluated, 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 these lots.

Event Description

A doctor alleged that four (4) patients had experienced sensitivity after treatment using optibond xtr.This is the first of four (4) reports.

• Brand Name: OPTIBOND XTR
• Type of Device: AGENT, 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: mark dzendzel ; 1717 west collins avenue; orange, CA 92867 ; 7145167802
• MDR Report Key: 5309131
• MDR Text Key: 33830949
• Report Number: 2024312-2015-00084
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/18/2015

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: 35106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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