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

Catalog Number 33872

Device Problem Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 03/01/2012

Event Type  Injury  

Event Description

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

Manufacturer Narrative

Specific patient information with regard to age and weight was not provided.The doctor noticed the discolorations on teeth #8 and #9 during a routine visit.On (b)(6), 2014, the patient had experienced the debonding of a crown for tooth #9.Upon the patient return visit, the doctor re-cemented the crown for the patient, without further incident.To date, the patient is doing fine.The doctor has not decided on a specific treatment for treating tooth #8 and will update kerr with any additional information.The product 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: 3759305
• MDR Text Key: 4551564
• Report Number: 2024312-2014-00278
• 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: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• 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: 03/25/2014
• 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