PROPILE GT ROTARY INSTRUMENT GTR0804025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-04-13 for PROPILE GT ROTARY INSTRUMENT GTR0804025 manufactured by Dentsply Tulsa.

Event Text Entries

[20162644] Doctor reported that a file separated in the canal during a procedure. The doctor, after unsuccessfully attempting to retrieve the separated piece, ultimately extracted the tooth to preclude permanent damage to a body structure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2320721-2005-00110
MDR Report Key591059
Report Source05
Date Received2005-04-13
Date of Report2005-03-14
Date of Event2005-03-14
Date Mfgr Received2005-03-14
Date Added to Maude2005-04-14
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 Location0
Manufacturer ContactDR PATRICIA KIHN
Manufacturer Street221 W. PHILA. ST., SUITE 60 SUSQUEHANNA COMMERCE CENTR W.
Manufacturer CityYORK PA 17404
Manufacturer CountryUS
Manufacturer Postal17404
Manufacturer Phone7178457511
Manufacturer G1DENTSPLY TULSA
Manufacturer Street608 ROLLING HILLS DRIVE
Manufacturer CityJOHNSON CITY TN 37604
Manufacturer CountryUS
Manufacturer Postal Code37604
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROPILE GT ROTARY INSTRUMENT
Generic NameDENTAL FILE
Product CodeEMR
Date Received2005-04-13
Model NumberNA
Catalog NumberGTR0804025
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key580916
ManufacturerDENTSPLY TULSA
Manufacturer Address* JOHNSON CITY TN * US
Baseline Brand NamePROFILE GT ROTARY INSTRUMENT
Baseline Generic NameDENTAL FILE
Baseline Model NoNA
Baseline Catalog NoGTR0804025
Baseline ID061902-761 (LOT
Baseline Device FamilyPROFILE GT
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2005-04-13

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