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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER X-SMART PLUS CONTRA ANGLE; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
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DENTSPLY MAILLEFER X-SMART PLUS CONTRA ANGLE; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL Back to Search Results
Catalog Number A103200000000
Device Problems Detachment of Device or Device Component (2907); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
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.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply (b)(4).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 there was poor rotor meaning that a x-smart contra angle won't hold files.The event outcome is unknown as of this mdr evaluation.
 
Manufacturer Narrative
The cartridge and cover is faulty which block drills.
 
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Brand Name
X-SMART PLUS CONTRA ANGLE
Type of Device
HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
Manufacturer (Section D)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ  1338
MDR Report Key9533712
MDR Text Key178621270
Report Number8031010-2019-00276
Device Sequence Number1
Product Code EGS
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA103200000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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