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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 Problems Loss of Data (2903); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received with a similar device 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 21cfr 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 was reported that a x-smart would not hold files; 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 Key8828430
MDR Text Key178544648
Report Number8031010-2019-00101
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K990682
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 10/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA100400000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2019
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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