FIBERKLEER 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 2014-02-19 for FIBERKLEER POST manufactured by Pentron Clinical.

Event Text Entries

[4204080] A doctor's office alleged that twenty (20) patient had experienced post failures after placement with fiberkleer post. This is the second of twenty (20) reports.
Patient Sequence No: 1, Text Type: D, B5


[11545561] Patient information with regard to gender, age and weight was not provided. Upon the patient's return visit, the doctor repeated the procedure, inserts metal posts and changed his bonding/cementation process. The doctor had a crown re-made and cemented for the patient. To date, the patient is doing fine. The product involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2024312-2014-00062
MDR Report Key3634726
Report Source05
Date Received2014-02-19
Date of Report2014-01-30
Date Mfgr Received2014-01-30
Date Added to Maude2014-02-19
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 NameFIBERKLEER POST
Generic NameROOT CANAL POST
Product CodeELR
Date Received2014-02-19
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 2014-02-19

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