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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC GT FIBER POST 1MM; POST, ROOT CANAL
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TULSA DENTAL PRODUCTS LLC GT FIBER POST 1MM; POST, ROOT CANAL Back to Search Results
Catalog Number GTPOSTF1
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Event Description
It was reported that a gt fiber post broke during use; no injury resulted.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
 
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Brand Name
GT FIBER POST 1MM
Type of Device
POST, ROOT CANAL
Manufacturer (Section D)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city, tn
MDR Report Key9923446
MDR Text Key188421673
Report Number2320721-2020-00043
Device Sequence Number1
Product Code ELR
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberGTPOSTF1
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/13/2020
Patient Sequence Number1
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