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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

A doctor alleged that three (3) patients had experienced the loss of a crown approximately one (1) month after placement with the maxcem elite product.This is the first of three (3) reports.

Manufacturer Narrative

Patient specifics with regard to gender, age, and weight were not provided.Although the doctor identified two (2) different lots associated with the loss of a crown, he could not verify which catalog number or lot number was used on the patient; therefore, no catalog numbers or lot numbers were identified in this report.The lots involved in the alleged incident included lot numbers 4772309 (catalog #33874) and 5049097 (catalog #33872).The doctor cleaned out the patient's crown and re-cemented it using a different product.To date, the patient is doing fine.The product from both lot numbers was returned and a physical evaluation was performed, yielding results within specifications.In addition, no similar complaints were received with regard to both lots.

• Brand Name: MAXCEM ELITE
• Type of Device: DENTAL CEMENT
• 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 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 3803496
• MDR Text Key: 4365590
• Report Number: 2024312-2014-00286
• 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: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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