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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VDW GMBH C-PILOT FILES CC+ STERILE; FILE, PULP CANAL, ENDODONTIC

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VDW GMBH C-PILOT FILES CC+ STERILE; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number V040368025015
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.A dhr review was conducted with no discrepancies noted.
 
Event Description
In this event it was reported that a c-pilot file broke during use.The broken piece could not be removed and was incorporated into the filling.
 
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Brand Name
C-PILOT FILES CC+ STERILE
Type of Device
FILE, PULP CANAL, ENDODONTIC
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 Key12960146
MDR Text Key281911175
Report Number9611053-2021-00434
Device Sequence Number1
Product Code EKS
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
EXEMPT
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 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberV040368025015
Device Lot Number357831
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/10/2021
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? No
Type of Device Usage Unknown
Patient Sequence Number1
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