CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE 607.01.570

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-03-16 for CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE 607.01.570 manufactured by Dentsply Detrey Gmbh.

Event Text Entries

[70072636] Therefore, because a serious injury resulted in this event, it is reportable per 21 cfr part 803. This report is for the fourth patient. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10


[70072637] It was reported that four patients experienced severe pain after having a filling with ceram-x universal. The clinician removed the ceram-x fillings in all four patients and replaced them with voco composite or glass ionomer (non-dentsply products). The pain disappeared within 48 hours for each patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010638-2017-00004
MDR Report Key6408961
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2017-03-16
Date of Report2017-02-24
Date Mfgr Received2017-01-26
Date Added to Maude2017-03-16
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 FDA3
Event Location3
Manufacturer ContactMRS. HELEN LEWIS
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178457551
Manufacturer G1DENTSPLY DETREY GMBH
Manufacturer StreetDETREY STRASSE 1
Manufacturer CityKONSTANZ, 78467
Manufacturer CountryGM
Manufacturer Postal Code78467
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE
Generic NameMATERIAL, TOOTH SHADE, RESIN
Product CodeEBF
Date Received2017-03-16
Model NumberNA
Catalog Number607.01.570
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY DETREY GMBH
Manufacturer AddressDETREY STRASSE 1 KONSTANZ, 78467 GM 78467


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-03-16

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