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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 Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2022
Event Type  malfunction  
Manufacturer Narrative
While there is no indication that serious injury resulted in this event, 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.After inspection, the cartridge, neck and head cap were replaced.
 
Event Description
In this event it was reported that a x-smart stopped during use.The file got stuck.There was no patient's injury.
 
Manufacturer Narrative
Received: 1x x-smart cartridge h1004c5210150.1x x-smart head cap h1004c5210500.1x x-smart neck h1004c5470220.X-smart cartridge: sav various mechanical problem.The file is hard to remove.
 
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Brand Name
X-SMART W/CONTRA ANGLE EUR
Type of Device
HANDPIECE, 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 Key14564722
MDR Text Key300807343
Report Number8031010-2022-00569
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 11/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberA100400000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date05/20/2022
Initial Date Manufacturer Received 05/20/2022
Initial Date FDA Received06/01/2022
Supplement Dates Manufacturer Received05/20/2022
Supplement Dates FDA Received11/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage A
Patient Sequence Number1
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