MAXCEM ELITE 33872

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-03 for MAXCEM ELITE 33872 manufactured by Kerr Corporation.

Event Text Entries

[4861126] A doctor alleged that approximately five (5) patients had experienced the debonding of a crown after placement with the maxcem elite clear product. This is the second of five (5) complaints.
Patient Sequence No: 1, Text Type: D, B5


[11917906] Specific information with regard to the patient's gender, age, and weight was not provided. The patient returned to the office and the doctor cleaned out and re-cemented the restoration using maxcem elite, without further incident. To date, the patient is doing fine. The product involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted. The doctor reported that he did not use the automix tips provided in the maxcem elite packaging as stated in the directions for use. He was aware that a new tip is intended to be used for each patient; however, in an attempt to save on "wasted product", he had extruded the material onto a mixing pad directly from the uncapped syringe and mixed the product by hand. It has been concluded that the intentional failure to follow instructions was the root cause of this incident. The doctor was informed by kerr on proper product usage.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2024312-2014-00597
MDR Report Key4055184
Report Source05
Date Received2014-09-03
Date of Report2014-08-19
Date Mfgr Received2014-08-19
Date Added to Maude2014-09-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMRS. KERRI CASINO
Manufacturer Street1717 W COLLINS AVE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167634
Manufacturer G1KERR CORPORATION
Manufacturer Street1717 WEST COLLINS AVENUE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal Code92867
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAXCEM ELITE
Generic NameDENTAL CEMENT
Product CodeMZW
Date Received2014-09-03
Catalog Number33872
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKERR CORPORATION
Manufacturer Address1717 WEST COLLINS AVENUE ORANGE CA 92867 US 92867


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2014-09-03

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