K-REAMER V010058025045

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 2017-01-06 for K-REAMER V010058025045 manufactured by Dentsply Vdw Gmbh.

Event Text Entries

[64130987] 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. Only unused product was returned for evaluation. The device was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10


[64130988] In this case a customer reported that a k-reamer "handle gets loose from the shaft. " treatment was completed. The dentist was not willing to provide more information.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611053-2016-00070
MDR Report Key6230845
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2017-01-06
Date of Report2017-01-06
Date Mfgr Received2016-12-08
Date Added to Maude2017-01-06
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 VDW GMBH
Manufacturer StreetBAYERWALDSTRASSE 15
Manufacturer CityMUNICH, 81737
Manufacturer CountryGM
Manufacturer Postal Code81737
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameK-REAMER
Generic NameREAMER, PULP CANAL, ENDODONTIC
Product CodeEKP
Date Received2017-01-06
Returned To Mfg2016-12-08
Model NumberNA
Catalog NumberV010058025045
Lot Number1012001721
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY VDW GMBH
Manufacturer AddressBAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737


Patients

Patient NumberTreatmentOutcomeDate
10 2017-01-06

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