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

Catalog Number 33872

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 02/19/2014

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced the loss of an onlay within one (1) day of placement with the maxcem elite clear product.

Manufacturer Narrative

The patient was due to return to the office on 02/20/14 for re-cementation of the onlay.Multiple attempts were made to contact the complainant in order to obtain further patient health information; however, the complainant has remained unresponsive.Kerr corporation has requested that the customer report any new information with regard to this patient.An update will be provided if any new information becomes available.The product was returned and a physical evaluation was performed, 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 this lot.

• 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: 3685912
• MDR Text Key: 4239500
• Report Number: 2024312-2014-00168
• 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: 02/20/2014

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 Expiration Date: 10/01/2014
• Device Catalogue Number: 33872
• Device Lot Number: 4803748
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2013
• 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
• Treatment: MONOBOND PLUS; G5 ALL-PURPOSE DESENSITIZER
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 77