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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENTRON CLINICAL FIBERKLEER POST; ROOT CANAL POST
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PENTRON CLINICAL FIBERKLEER POST; ROOT CANAL POST Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
A doctor's office alleged that twenty (20) patient had experienced post failures after placement with fiberkleer post.This is the sixth of twenty (20) reports.
 
Manufacturer Narrative
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.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.
 
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Brand Name
FIBERKLEER POST
Type of Device
ROOT CANAL POST
Manufacturer (Section D)
PENTRON CLINICAL
1717 west collins avenue
orange 92867
Manufacturer (Section G)
PENTRON CLINICAL
1717 west collins avenue
orange CA 92867
Manufacturer Contact
kerri casino
1717 west collins avenue
orange, CA 92867
7145167634
MDR Report Key3634775
MDR Text Key4178977
Report Number2024312-2014-00066
Device Sequence Number1
Product Code ELR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K983266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 01/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/30/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
DUAL CURE CEMENT; LIGHT CURE DIRECT BONDING AGENT; RIVA BOND
Patient Outcome(s) Other; Required Intervention;
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