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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL X-SMART W/CONTRA ANGLE EUR HANDPIECE, DIRECT DRIVE, AC-POWERED

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MAILLEFER INSTRUMENTS HOLDING SARL X-SMART W/CONTRA ANGLE EUR HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number A100400000000
Device Problems Detachment of Device or Device Component (2907); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
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. 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 it was reported that an x-smart contra angle won't hold files; no injury resulted.
 
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Brand NameX-SMART W/CONTRA ANGLE EUR
Type of DeviceHANDPIECE, DIRECT DRIVE, AC-POWERED
Manufacturer (Section D)
MAILLEFER INSTRUMENTS HOLDING SARL
ch. du verger 3
ballaigues vaud CH-13 38
SZ CH-1338
Manufacturer (Section G)
MAILLEFER INSTRUMENTS HOLDING SARL
ch. du verger 3
ballaigues vaud CH-13 38
SZ CH-1338
Manufacturer Contact
hannah seevaratnam
221 west philadelphia st.
york, PA 17401
7178457511
MDR Report Key13417271
MDR Text Key287135102
Report Number8031010-2022-00435
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeIN
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,Followup
Report Date 05/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberA100400000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2022
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date01/20/2022
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage

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