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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY VDW GMBH VDW.CONNECT DRIVE; CONTROLLER, FOOT, HANDPIECE AND CORD
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DENTSPLY VDW GMBH VDW.CONNECT DRIVE; CONTROLLER, FOOT, HANDPIECE AND CORD Back to Search Results
Catalog Number V041181000000
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/23/2018
Event Type  malfunction  
Manufacturer Narrative
Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona.Handpiece (motor doesn't turn) defective, replaced with 08504.Contra angle 04045 and charger without errors.
 
Event Description
In this event it was reported a vdw.Connect was improperly auto-reversing; no injury occurred.
 
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Brand Name
VDW.CONNECT DRIVE
Type of Device
CONTROLLER, FOOT, HANDPIECE AND CORD
Manufacturer (Section D)
DENTSPLY VDW GMBH
bayerwaldstrasse 15
munich, 81737
GM  81737
Manufacturer (Section G)
DENTSPLY VDW GMBH
bayerwaldstrasse 15
munich, 81737
GM   81737
Manufacturer Contact
karl nittinger
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494424
MDR Report Key8186841
MDR Text Key131129187
Report Number9611053-2018-00239
Device Sequence Number1
Product Code EBW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberV041181000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/23/2018
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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