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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER K-FILE M-ACCESS; FILE, PULP CANAL, ENDODONTIC

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DENTSPLY MAILLEFER K-FILE M-ACCESS; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number A12MA02500812
Device Problems Material Discolored (1170); Fracture (1260); Device Operates Differently Than Expected (2913); Compatibility Problem (2960)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.This report is for the second file.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
 
Event Description
In this event a customer reported that two k-files did not exhibit the characteristics of our product because they fractured, are irregular sizes, have faded color plastic handle, and had a different label with our identification.Additional information has been requested, but is not yet available.
 
Manufacturer Narrative
After analysis, the returned files do not meet maillefer quality standards and are obviously counterfeit.Moreover, the batch number has no corresponding with the reference (b)(4) in our system.The container and its labelling are equally recognized as fakes.
 
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Brand Name
K-FILE M-ACCESS
Type of Device
FILE, PULP CANAL, ENDODONTIC
Manufacturer (Section D)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ  1338
Manufacturer (Section G)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ   1338
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key5138451
MDR Text Key28080253
Report Number8031010-2015-00049
Device Sequence Number1
Product Code EKS
Combination Product (y/n)N
Reporter Country CodeBR
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 Followup
Report Date 09/09/2015
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 Operator Health Professional
Device Catalogue NumberA12MA02500812
Device Lot Number2350190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/08/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/18/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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