CERCON BASE DISK WHITE 20 MM 66080020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-21 for CERCON BASE DISK WHITE 20 MM 66080020 manufactured by Dentsply Prosthetics.

Event Text Entries

[58134849] While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[58134850] A dental lab reported a possible allergic reaction a patient was experiencing from a (b)(6) unit bridge fashioned with cercon base. The patient reported experiencing a burning sensation on the tissue in the area of the bridge. Removal of the device alleviates the patient's symptoms.
Patient Sequence No: 1, Text Type: D, B5


[60947066] The returned bridge was in the mouth for over 9 months and did not have a lot number associated to investigate further. Zirconia is not likely to cause an allergic reaction, the customer will also be informed to relay to the clinician that the patient should undergo allergy testing and also look to possible causes relating to cement used as well as stain and glaze applied to the bridge by the dental lab.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2647456-2016-00001
MDR Report Key6049469
Date Received2016-10-21
Date of Report2016-09-22
Date Mfgr Received2016-11-09
Date Added to Maude2016-10-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. HELEN LEWIS
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494229
Manufacturer G1DEGUDENT GMBH
Manufacturer StreetRODENBACHER CHAUSSEE 4
Manufacturer CityHANAU, HESSEN 63457
Manufacturer CountryGM
Manufacturer Postal Code63457
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCERCON BASE DISK WHITE 20 MM
Generic NamePOWDER, PORCELAIN
Product CodeEIH
Date Received2016-10-21
Returned To Mfg2016-10-10
Model NumberNA
Catalog Number66080020
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY PROSTHETICS
Manufacturer Address570 WEST COLLEGE AVENUE YORK PA 17404 US 17404


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-10-21

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