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

Catalog Number 29848

Device Problem Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

A doctor's office alleged that the hardness of the herculite xrv composite was inconsistent after polymerization during procedures on multiple patients.

Manufacturer Narrative

Specific information regarding the exact number or patients involved, genders, ages, or weights was not provided.The doctor reported that after light curing, some areas of the composite would be fully set whereas other areas of the composite would still be soft.The doctor drilled out the composite and replaced the restoration during the same office visit for each of the patients.To date, each of the patients are doing fine.The product involved in the alleged incident was not returned; therefore, a physical evaluation was performed on a retained sample from the same lot, yielding results within specifications.In addition, no similar complaints were received with regard to this lot.

• 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: 4065080
• MDR Text Key: 4898555
• Report Number: 2024312-2014-00591
• 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: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 07/01/2016
• Device Catalogue Number: 29848
• Device Lot Number: 5068235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2014
• 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