DENTSPLY MAILLEFER X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE; HANDPIECE, DIRECT DRIVE, AC-POWERED
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Catalog Number A100400000000 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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There has been a previous report received for 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 has not been returned as of this report.Evaluation results will be submitted as they become available.
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Event Description
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In this event it was reported that a x-smartcontra angle did not hold files.The event outcome is unknown as of this mdr evaluation.
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Manufacturer Narrative
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Additional information has been received indicating that no injury resulted.X-smart head cap, bad maintenance (user), the file is hard to remove, this failure is probably caused by rust or other foreign matter in the head cap.X-smart cartridge, various mechanical problem, the file does not fit on the contra angle because hook of cartridge is broken.Replaced 1 x cartridge h1004c5210150 and 1 x x head cap h1004c5210500.
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Search Alerts/Recalls
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