MAXCEM ELITE 34418

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 2014-09-19 for MAXCEM ELITE 34418 manufactured by Kerr Corporation.

Event Text Entries

[4756674] A doctor's office alleged that six (6) patients had experienced the debonding of a crown approximately one (1) to two (2) weeks after placement with the maxcem elite bulk product. This is the second of six (6) complaints.
Patient Sequence No: 1, Text Type: D, B5


[12353403] Specific information with regard to the patient's gender, age, and weight was not provided. The patient retrieved the crown and returned to the office. The doctor cleaned out and re-cemented the crown using a different product. To date, the patient is doing fine. A physical evaluation was performed on the returned product, 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2024312-2014-00617
MDR Report Key4102092
Report Source05
Date Received2014-09-19
Date of Report2014-08-26
Date Mfgr Received2014-08-26
Device Manufacturer Date2014-03-15
Date Added to Maude2014-09-19
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 Received2014-09-19
Catalog Number34418
Lot Number5121925
Device Expiration Date2015-08-01
OperatorDENTIST
Device AvailabilityY
Device Eval'ed by MfgrY
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 2014-09-19

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