RADIX-ANKER C019300000200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for RADIX-ANKER C019300000200 manufactured by Dentsply Maillefer.

Event Text Entries

[35494225] Because this event resulted in a serious injury, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur. As such, this event meets the definition of a reportable event per 21 cfr part 803. This report is for the first device. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[35494226] In this event it was reported that two radix-anker posts fractured. Surgical intervention was necessary to remove the broken piece ("the tooth was pulled").
Patient Sequence No: 1, Text Type: D, B5


[37863571] Multiple unsuccessful attempts were made to obtain the device for evaluation. 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


MAUDE Entry Details

Report Number8031010-2015-00065
MDR Report Key5354793
Date Received2016-01-08
Date of Report2015-12-09
Date Mfgr Received2016-01-14
Date Added to Maude2016-01-08
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 Phone7178494229
Manufacturer G1DENTSPLY MAILLEFER
Manufacturer StreetCHEMIN DU VERGER 3
Manufacturer CityBALLAIGUES, 1338
Manufacturer CountrySZ
Manufacturer Postal Code1338
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRADIX-ANKER
Generic NamePOST, ROOT CANAL
Product CodeELR
Date Received2016-01-08
Model NumberNA
Catalog NumberC019300000200
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY MAILLEFER
Manufacturer AddressCHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-01-08

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