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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY VDW GMBH VDW GOLD/SILVER CONTRA ANGLE; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
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DENTSPLY VDW GMBH VDW GOLD/SILVER CONTRA ANGLE; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL Back to Search Results
Catalog Number V041079000000
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
There has been a previous report received with a similar device 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 vdw.Gold/silver contra angle 6:1 won't hold files.The event outcome is unknown as of this mdr evaluation.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation.
 
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Brand Name
VDW GOLD/SILVER CONTRA ANGLE
Type of Device
HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
Manufacturer (Section D)
DENTSPLY VDW GMBH
bayerwaldstrasse 15
munich, 81737
GM  81737
MDR Report Key11646657
MDR Text Key247941675
Report Number9611053-2021-00113
Device Sequence Number1
Product Code EGS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberV041079000000
Was Device Available for Evaluation? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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