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

Catalog Number 33872

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced the debonding of a veneer approximately one (1) month after placement with the maxcem elite clear product.

Manufacturer Narrative

Maxcem elite instructions for use state: "for veneer cementation using maxcem elite, adhesive application on tooth prep is required." the doctor reported that an adhesive had not been applied to the tooth prior to initial cementation.The patient had returned to the office on (b)(4) 2014 and the veneer was cleaned out and re-cemented using maxcem elite along with an adhesive application.To date, the patient is doing fine.The product involved in the alleged incident was not returned and no lot number was provided; 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: 3967961
• MDR Text Key: 16186899
• Report Number: 2024312-2014-00545
• 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: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 07/30/2014
• 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: 21 YR
• Patient Weight: 50