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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL X-SMART PROTAPER INTROC.EUR HANDPIECE, DIRECT DRIVE, AC-POWERED

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MAILLEFER INSTRUMENTS HOLDING SARL X-SMART PROTAPER INTROC.EUR HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number A100800000200
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2022
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. After inspection of device, cartridge and head cap replaced.
 
Event Description
In this event it is reported that a x-smart protaper introc. Eur won't hold files. Failure found before use on patient. No injury occurred.
 
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Brand NameX-SMART PROTAPER INTROC.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 Key14238765
MDR Text Key290473623
Report Number8031010-2022-00525
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberA100800000200
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date04/19/2022
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage

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