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

Catalog Number 33872

Device Problems Loss of or Failure to Bond (1068); Material Discolored (1170)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor alleged that after final cementation with the maxcem elite clear, a patient had experienced discoloration under veneers for tooth #8 and #9, and eight (8) days after placement had experienced the loss of a veneer from tooth #9.

Manufacturer Narrative

It was reported by the doctor that at the time of cementation on (b)(6) 2014, she had noticed that the product was not clear and had discolored the veneers; however, she continued the cementation procedure.The veneer from tooth #9 had delaminated on (b)(6) 2014 and the patient returned to the office.The doctor temporarily spotted the veneer back on.The patient returned to the office on (b)(6) 2014 and a new impression was taken.New veneers for tooth #8 and #9 have been made and will be cemented during a future follow up appointment.To date, the patient is doing fine.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: 3731195
• MDR Text Key: 15113508
• Report Number: 2024312-2014-00257
• 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: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 07/01/2013
• Device Catalogue Number: 33872
• Device Lot Number: 4664824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2014
• 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; Required Intervention
• Patient Age: 22 YR