• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DENTSPLY MAILLEFER X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number A100400000000
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
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. In this event, no injury was reported. The file is not held by the contra angle, this is a known failure mode that can be resulted from various causes the number of reuse of the instrument, the experience of the dentist, an issue with the contra angle/motor, or a defect in the instrument.
 
Event Description
In this event it was reported that a x-smart plus contra angle won't hold burs. The dentist noticed the issue before use. No injury resulted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameX-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE
Type of DeviceHANDPIECE, DIRECT DRIVE, AC-POWERED
Manufacturer (Section D)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ 1338
MDR Report Key12704355
MDR Text Key278571791
Report Number8031010-2021-00238
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
PMA/PMN Number
K990682
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
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 Manufacturer09/27/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2021
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

-
-