MAUDE Adverse Event Report: KERR CORPORATION HERCULITE ULTRA; MATERIAL, TOOTH SHADE, RESIN

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor's office alleged that the herculite ultra composite did not polymerize during procedures on approximately twenty (20) patients.This is the fifteenth of twenty (20) reports.

Manufacturer Narrative

Although the doctor identified fourteen (14) different lots associated with not curing, the doctor could not verify which lot was used on the patient.The lots involved in the alleged incident include 4586772, 4594223, 4862345, 4916637, 4982755, 4996028, 4950206, 4960403, 4201571, 4568733, 4211007, 4397297, 3694407, and 4665691.Patient specifics with regard to gender, age, and weight were not provided.The cured and uncured composite was drilled out and replaced using a new herculite ultra tip during the same office visit.To date, the patient is doing fine.The product involved in the alleged incident has not been returned.An evaluation of retained samples is anticipated, but has not yet begun.

Manufacturer Narrative

The lot numbers involved in the alleged incidents were not returned; therefore, a physical evaluation was performed on a retained sample for each of the lots, yielding results within specifications.In addition, no similar complaints were received with regard to any of these lots.

• Brand Name: HERCULITE ULTRA
• Type of Device: MATERIAL, TOOTH SHADE, 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: 3624748
• MDR Text Key: 4174540
• Report Number: 2024312-2014-00101
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K082671
• 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: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2014
• 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
• Treatment: XT BOND; FLOW-IT
• Patient Outcome(s): Other