PROPEX PIXI APEX LOCATOR A103000000100

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 2020-02-22 for PROPEX PIXI APEX LOCATOR A103000000100 manufactured by Dentsply Maillefer.

Event Text Entries

[180519292] While no serious injury resulted in this event, there has been a previous report received 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 (b)(4). Slight fluctuation in the lower measured value. "0. 0" does not light up permanently. The file clip has a cable break.
Patient Sequence No: 1, Text Type: N, H10


[180519293] In this event it was reported that a propex pixi apex locator was giving incorrect measurements; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8031010-2020-00019
MDR Report Key9742773
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-02-22
Date of Report2020-02-22
Date Mfgr Received2020-01-23
Date Added to Maude2020-02-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
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 G1FORUM ENGINEERING TECHNOLOGIES (96) LTD.
Manufacturer Street1 PLATIN STR. NEW INDUSTRIAL ZONE
Manufacturer CityRISHON LEZION HAMERKAZ, 7565339
Manufacturer CountryIS
Manufacturer Postal Code7565339
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROPEX PIXI APEX LOCATOR
Generic NameLOCATOR, ROOT APEX
Product CodeLQY
Date Received2020-02-22
Returned To Mfg2020-01-24
Model NumberNA
Catalog NumberA103000000100
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY MAILLEFER
Manufacturer AddressCHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-22

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