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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY LLC X-POST; POST, ROOT CANAL
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DENTSPLY LLC X-POST; POST, ROOT CANAL Back to Search Results
Catalog Number 60667333
Device Problem Break (1069)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
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.The event outcome is unknown as of this mdr evaluation.
 
Event Description
In this event it was reported that an x-post refill broke in the tooth.The outcome of the event is unknown as of this mdr evaluation.
 
Manufacturer Narrative
The teeth had to be removed after the pins were fractured.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.
 
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Brand Name
X-POST
Type of Device
POST, ROOT CANAL
Manufacturer (Section D)
DENTSPLY LLC
38 west clarke avenue
milford DE 19963
MDR Report Key8577908
MDR Text Key144148670
Report Number8031010-2019-00043
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 foreign,health professional
Type of Report Initial,Followup
Report Date 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number60667333
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/11/2019
Patient Sequence Number1
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