GT FIBER POST 1.25MM GTPOSTF2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-01 for GT FIBER POST 1.25MM GTPOSTF2 manufactured by Tulsa Dental Products Llc.

Event Text Entries

[140620008] While no serious injury resulted in this event, 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. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10


[140620009] It was reported that a gt fiber post broke during use; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2320721-2019-00057
MDR Report Key8471614
Report SourceHEALTH PROFESSIONAL
Date Received2019-04-01
Date of Report2019-03-30
Date Mfgr Received2019-02-28
Date Added to Maude2019-04-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
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 Report3

Device Details

Brand NameGT FIBER POST 1.25MM
Generic NamePOST, ROOT CANAL
Product CodeELR
Date Received2019-04-01
Model NumberNA
Catalog NumberGTPOSTF2
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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 2019-04-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.