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

Catalog Number 29835

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Date 05/15/2014

Event Type  Injury  

Event Description

A doctor's office alleged that voids and open margins appeared on x-rays after placement of the herculite xrv composite for two (2) patients.This is the first of two (2) reports.

Manufacturer Narrative

The doctor identified two (2) different lots associated with the voids; therefore, no lot numbers were identified in this report.The lots involved in the alleged incidents include lot numbers 5045224 and 4951193.The doctor cut out the composite for teeth #4 and #6 and refilled the preps again using the same product.The doctor took another x-ray and voids and open margins appeared; however, the doctor was certain that no voids or open margins were present.The patient did not want the doctor to re-do the restoration.To date, the patient is doing fine.The products alleged in this incident were not returned; therefore, a void test was performed on the retain samples for lots 5045224 and 4951193, 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 regard to these lots.

• Brand Name: HERCULITE XRV
• 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: 3881399
• MDR Text Key: 4509484
• Report Number: 2024312-2014-00429
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943642
• 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: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 29835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2010
• 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
• Patient Age: 59 YR
• Patient Weight: 86