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

Catalog Number 33872

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced the debonding of a veneer that had been cemented with maxcem elite.

Manufacturer Narrative

The office did not provide any specific information regarding the maxcem elite which had been used on the patient; therefore, no lot number or expiration date was identified.The doctor reported that the patient had four (4) veneers placed for teeth numbers 7,8, 9 and 10 and had experienced the chipping of the incisial edge of veneers on teeth #9 and #10; however, the doctor does not recall which product was used to cement the veneers.The doctor re-cemented the veneers using maxcem elite.On (b)(6) 2014, the patient returned to the doctor's office with tooth #9 debonded.During a follow up phone call with two (2) doctor's assistants on (b)(6) 2014, it was not definitive whether or not the doctor re-cemented the tooth for the patient or whether or not maxcem elite was used.The product was not returned and no lot number was provided; therefore, no evaluation was provided.

• 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: 4048711
• MDR Text Key: 4813036
• Report Number: 2024312-2014-00602
• 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: 08/11/2014

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: 08/11/2014
• Initial Date FDA Received: 08/29/2014
• 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: 65 YR
• Patient Weight: 86