ZEKRYA BUR E015134100000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for ZEKRYA BUR E015134100000 manufactured by Dentsply Maillefer.

Event Text Entries

[136233149] Per condition #1 of exemption (b)(4), events meeting the definition of a serious injury are required to be reported. Therefore, because of the separated piece was removed surgically, this event meets the criteria for reportability per 21 cfr part 803. 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


[136233150] In this event it was reported that a carb. B. Surgery zekrya separated during first use inside the bone; the customer had to perform surgery to removed the broken piece.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8031010-2019-00004
MDR Report Key8340482
Date Received2019-02-14
Date of Report2019-04-11
Date Mfgr Received2019-03-07
Date Added to Maude2019-02-14
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 ContactMR. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
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 Report0

Device Details

Brand NameZEKRYA BUR
Generic NameBUR, DENTAL
Product CodeEJL
Date Received2019-02-14
Model NumberNA
Catalog NumberE015134100000
Lot Number1463637
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 2019-02-14

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