X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE A100400000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE A100400000000 manufactured by Dentsply Maillefer.

Event Text Entries

[184628709] There has been a previous report received with a similar device where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr 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


[184628710] In this event it was reported that a x-smart contra angle won't hold files; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8031010-2020-00024
MDR Report Key9760597
Date Received2020-02-27
Date of Report2020-02-26
Date Mfgr Received2020-01-27
Date Added to Maude2020-02-27
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
Manufacturer CountryUS
Manufacturer Phone8494424
Manufacturer G1NAKANISHI INC.
Manufacturer Street700 SHIMOHINATA
Manufacturer CityKANUMA-SHI, 322-8666
Manufacturer CountryJA
Manufacturer Postal Code322-8666
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameX-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE
Generic NameHANDPIECE, DIRECT DRIVE, AC-POWERED
Product CodeEKX
Date Received2020-02-27
Model NumberNA
Catalog NumberA100400000000
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY MAILLEFER
Manufacturer AddressCHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-27

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