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

Catalog Number V040368025015

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Because a serious injury resulted, this event is reportable per 21 cfr part 803.A dhr review was conducted with no discrepancies noted.

Event Description

In this event it was reported that a c-pilot files cc+ sterile broke during use.The broken piece could not be retrieved so the patient's tooth was extracted.

• 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 Key: 12960111
• MDR Text Key: 281910754
• Report Number: 9611053-2021-00432
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• 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 Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: V040368025015
• Device Lot Number: 357831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/10/2021
• Date Manufacturer Received: 11/10/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability