MAUDE Adverse Event Report: KERR CORPORATION MAXCEM ELITE; CEMENT, DENTAL

Catalog Number 33872

Device Problem Material Discolored (1170)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced discoloration of a veneer after placement with maxcem elite clear.

Manufacturer Narrative

Specific patient information with regard to age and weight was not provided.The doctor noticed the discoloration immediately after light curing the material; however, the patient approved the veneer and left the office after the procedure.The next day the patient contacted the doctor and was not happy with the veneer.The doctor stated that he believes the maxcem elite clear was not the cause of the discoloration and believes that the patient's tooth structure was showing through the veneer, causing the discoloration.The doctor learned through a follow-up phone call to the patient a few days after the procedure that the patient had reportedly forced the veneer off.Further patient or incident information cannot be obtained as the patient will no longer return to the doctor's office.The lot number involved in the alleged incident was past expiration and the product has not been returned; therefore, no evaluation can be conducted.

• Brand Name: MAXCEM ELITE
• Type of Device: CEMENT, DENTAL
• 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 w collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 3746298
• MDR Text Key: 4418600
• Report Number: 2024312-2014-00264
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073209
• 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: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 33872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2014
• 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
• Patient Outcome(s): Other