K-REAMERS, CC+, STERILE V040353025030

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 2019-02-07 for K-REAMERS, CC+, STERILE V040353025030 manufactured by Dentsply Vdw Gmbh.

Event Text Entries

[135386808] While no injury was reported, 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. Received used product upper part small pieces, therefore was an investigation from the small pieces not possible and lot number was also not available. No unused instruments available. Root causes are unknown for the breakage.
Patient Sequence No: 1, Text Type: N, H10


[135386809] In this event it was reported that a k-reamer broke during use. The separated piece could not be retrieved and remained in the canal.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611053-2019-00003
MDR Report Key8315721
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-02-07
Date of Report2019-02-07
Date Mfgr Received2019-01-08
Date Added to Maude2019-02-07
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 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-REAMERS, CC+, STERILE
Generic NameREAMER, PULP CANAL, ENDODONTIC
Product CodeEKP
Date Received2019-02-07
Returned To Mfg2019-01-15
Model NumberNA
Catalog NumberV040353025030
Lot NumberUNK
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 2019-02-07

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