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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY VDW GMBH ROOT FILLERS -L-; INSTRUMENT, FILLING, PLASTIC, DENTAL
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DENTSPLY VDW GMBH ROOT FILLERS -L-; INSTRUMENT, FILLING, PLASTIC, DENTAL Back to Search Results
Catalog Number V040393025030
Device Problem Break (1069)
Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Manufacturer Narrative
There has been a previous report with the same product 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
In this event it was reported that a root filler broke in a patient's tooth.The tooth was filled with broken part incorporated.
 
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.
 
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Brand Name
ROOT FILLERS -L-
Type of Device
INSTRUMENT, FILLING, PLASTIC, DENTAL
Manufacturer (Section D)
DENTSPLY VDW GMBH
bayerwaldstrasse 15
munich, 81737
GM  81737
MDR Report Key8024753
MDR Text Key125773727
Report Number9611053-2018-00174
Device Sequence Number1
Product Code EIY
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 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberV040393025030
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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