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 Information (3190)

Event Type  Injury  

Event Description

A doctor's office alleged that two (2) patients had experienced a debonding of restorations after placement with maxcem elite.This is the first of two (2) reports.

Manufacturer Narrative

Although the doctor identified two (2) different lots associated with the debonding, the doctor could not verify which lot was used on each of the patients; therefore, no lot numbers were identified in this report.The lots involved in the alleged incidents include lot numbers 5156204 and 5097554.Specific information with regard to the patient age and weight were not provided.The patient had experienced the debonding of a crown for tooth #8 two (2) days after placement.Upon the patient's return visit, the doctor cleaned and re-cemented the crown, without further incident.To date, the patient is doing fine.The products were not returned; therefore, an adhesive strength evaluation was performed on the retain sample, yielding results within specifications.A dhr review indicated that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to these lots.

• 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: 4138004
• MDR Text Key: 4794588
• Report Number: 2024312-2014-00629
• 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: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• 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: 09/04/2014
• 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