GT SMALL DRILL GTS1D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for GT SMALL DRILL GTS1D manufactured by Tulsa Dental Products Llc.

Event Text Entries

[123200446] There has been a previous report received where a broken drill 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. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[123200447] A gt small drill broke during shipment. No patient was involved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2320721-2018-00149
MDR Report Key7940280
Date Received2018-10-05
Date of Report2019-01-09
Date Mfgr Received2018-12-17
Date Added to Maude2018-10-05
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 G1TULSA DENTAL PRODUCTS LLC
Manufacturer Street608 ROLLING HILLS DRIVE
Manufacturer CityJOHNSON CITY TN 37604
Manufacturer CountryUS
Manufacturer Postal Code37604
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameGT SMALL DRILL
Generic NamePOST, ROOT CANAL
Product CodeELR
Date Received2018-10-05
Returned To Mfg2018-09-20
Model NumberNA
Catalog NumberGTS1D
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTULSA DENTAL PRODUCTS LLC
Manufacturer Address608 ROLLING HILLS DRIVE JOHNSON CITY TN 37604 US 37604


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-05

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