PROPOST POST3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-30 for PROPOST POST3 manufactured by Dentsply Tulsa Dental Specialties.

Event Text Entries

[63856803] 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. This report is for the second device. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[63856804] It was reported that two propost posts broke during placement in one patient. Both posts were retrieved and the dentist was able to seat another post and complete the restoration.
Patient Sequence No: 1, Text Type: D, B5


[73364492] Multiple unsuccessful attempts were made to obtain the device for evaluation. The lot number reported was found to be invalid. Therefore, retained-product testing and/or dhr review is not possible.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2320721-2016-00072
MDR Report Key6215787
Date Received2016-12-30
Date of Report2017-03-24
Date of Event2016-11-29
Date Mfgr Received2017-02-22
Date Added to Maude2016-12-30
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 ContactMRS. HELEN LEWIS
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494229
Manufacturer G1DENTSPLY TULSA DENTAL SPECIALTIES
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 NamePROPOST
Generic NamePOST, ROOT CANAL
Product CodeELR
Date Received2016-12-30
Model NumberNA
Catalog NumberPOST3
Lot Number83012216
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY TULSA DENTAL SPECIALTIES
Manufacturer Address608 ROLLING HILLS DRIVE JOHNSON CITY TN 37604 US 37604


Patients

Patient NumberTreatmentOutcomeDate
10 2016-12-30

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