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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VDW GMBH VDW.CONNECT DRIVE HANDPIECE WITHOUT CA; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

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VDW GMBH VDW.CONNECT DRIVE HANDPIECE WITHOUT CA; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL Back to Search Results
Catalog Number V041185000502
Device Problem Mechanical Problem (1384)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
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 21 cfr 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 is reported that a vdw.Connect drive handpiece without ca was involved in 3 file breakages at 3 different patients.This is 1 of 3 reports.The broken parts still remain in the root canal of the patient.
 
Manufacturer Narrative
2 (two) unsuccessful request for product return have been made and documented.Complaint will be reopened as soon as suspect product arrives per 8000-sop-038 [1].All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
 
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Brand Name
VDW.CONNECT DRIVE HANDPIECE WITHOUT CA
Type of Device
HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
Manufacturer (Section D)
VDW GMBH
bayerwaldstrasse 15
munich bayern 81737
GM  81737
Manufacturer (Section G)
VDW GMBH
bayerwaldstrasse 15
munich bayern 81737
GM   81737
Manufacturer Contact
hannah seevaratnam
221 west philadelphia st.
york, PA 17401
7178457511
MDR Report Key19018325
MDR Text Key339089461
Report Number9611053-2024-00063
Device Sequence Number1
Product Code EGS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 04/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberV041185000502
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date03/27/2024
Initial Date Manufacturer Received 03/27/2024
Initial Date FDA Received04/02/2024
Supplement Dates Manufacturer Received03/27/2024
Supplement Dates FDA Received04/12/2024
Was Device Evaluated by Manufacturer? No
Type of Device Usage A
Patient Sequence Number1
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