X-SMART PLUS CONTRA ANGLE A103200000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-01-09 for X-SMART PLUS CONTRA ANGLE A103200000000 manufactured by Dentsply Maillefer.

Event Text Entries

[178743781] 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. Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona. 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


[178743782] In this event it was reported that a x-smart plus contra angle won't hold files. The event outcome is unknown as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8031010-2019-00290
MDR Report Key9572866
Report SourceFOREIGN,OTHER
Date Received2020-01-09
Date of Report2020-03-02
Date Mfgr Received2019-12-03
Date Added to Maude2020-01-09
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 ContactMR. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
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 PLUS CONTRA ANGLE
Generic NameHANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
Product CodeEGS
Date Received2020-01-09
Model NumberNA
Catalog NumberA103200000000
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 2020-01-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.