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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER X-SMART ENDO MOTOR WITH CONTRA ANGLE HANPIECE HANDPIECE, DIRECT DRIVE, AC-POWERED

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DENTSPLY MAILLEFER X-SMART ENDO MOTOR WITH CONTRA ANGLE HANPIECE HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number A100400000000
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
There has been a previous report received where this malfunction has caused file separation. 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. X-smart plus head assembly; sav bad maintenance (user); head assembly is scratched. X-smart plus cartridge; sav various mechanical problem; makes an unusual noise and the movement is not fluid. X-smart plus head cap; sav various mechanical problem; the push button is blocked. X-smart plus bearing retainer; sav various mechanical problem; broken h1033c1051113. X-smart plus wave washer. Sav various mechanical problem. Rusted. X-smart plus drive shaft; sav various mechanical problem; rotation not fluid.
 
Event Description
In this event it was reported that a x-smart plus contra angle locked and stopped working during the procedure of root canal treatment; no injury resulted.
 
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Brand NameX-SMART ENDO MOTOR WITH CONTRA ANGLE HANPIECE
Type of DeviceHANDPIECE, DIRECT DRIVE, AC-POWERED
Manufacturer (Section D)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ 1338
Manufacturer (Section G)
NAKANISHI INC.
700 shimohinata
kanuma-shi, 322-8 666
JA 322-8666
Manufacturer Contact
karl nittinger
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494424
MDR Report Key8700804
MDR Text Key149793873
Report Number8031010-2019-00078
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodePK
PMA/PMN Number
K990682
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA100400000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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