FIBREKOR POST

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 2014-05-28 for FIBREKOR POST manufactured by Pentron Clinical.

Event Text Entries

[4407324] A doctor's office alleged that seven (7) patients had experienced the debonding of a fibrekor fiber post with the core and crown still attached. This is the third of seven (7) reports.
Patient Sequence No: 1, Text Type: D, B5


[11959395] Patient information with regard to gender, age, and weight was not provided. A new post and core was created. The doctor retrofitted the new post and core to the original crown and cemented it; however, the new post and core debonded with the original crown attached a second time. The patient returned to the office, and the doctor created a new post and core again. The doctor re-bonded the original crown to the new post and core. To date, the patient is doing fine. The product involved in the alleged incident was not returned and no lot number or catalog number was provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2024312-2014-00421
MDR Report Key3836913
Report Source05
Date Received2014-05-28
Date of Report2014-05-01
Date Mfgr Received2014-05-01
Date Added to Maude2014-05-29
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 FDA0
Event Location0
Manufacturer ContactMRS. KERRI CASINO
Manufacturer Street1717 WEST COLLINS AVENUE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167634
Manufacturer G1PENTRON CLINICAL
Manufacturer Street1717 WEST COLLINS AVENUE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal Code92867
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFIBREKOR POST
Generic NameROOT CANAL POST
Product CodeELR
Date Received2014-05-28
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPENTRON CLINICAL
Manufacturer Address1717 WEST COLLINS AVENUE ORANGE 92867 US 92867


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2014-05-28

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