PROFILE GT ROTARY INSTRUMENT GTR0602021

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 2004-11-05 for PROFILE GT ROTARY INSTRUMENT GTR0602021 manufactured by Dentsply Tulsa.

Event Text Entries

[599502] Doctor reported a file separated mid-root during a procedure. The separated piece was retrieved, and there is no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5


[7920551] In this incident, there was no report of injury to the patient. However, as a result of this malfunction, the potential for surgical intervention exists (though inadvisable per expert opinion provided by dr) to preclude injury or illnesss that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events. This event, therefore, is reportable per 21cfr part 803. Device ws not returned for evaluation and the lot number is not known for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2320721-2004-00492
MDR Report Key826582
Report Source05
Date Received2004-11-05
Date of Report2004-10-11
Date of Event2004-10-07
Date Mfgr Received2004-10-11
Date Added to Maude2007-03-13
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., STE. 60 SUSQUEHANNA COMMERCE CENTER W.
Manufacturer CityYORK PA 17404
Manufacturer CountryUS
Manufacturer Postal17404
Manufacturer Phone*
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 NamePROFILE GT ROTARY INSTRUMENT
Generic NameDENTAL FILE
Product CodeEKA
Date Received2004-11-05
Model NumberNA
Catalog NumberGTR0602021
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key813970
ManufacturerDENTSPLY TULSA
Manufacturer Address* JOHNSON CITY TN * US
Baseline Brand NamePROFILE GT ROTARY INSTRUMENT
Baseline Generic NameDENTAL FILE
Baseline Model NoNA
Baseline Catalog NoGTR0602021
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2004-11-05

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