DENTSPLY MAILLEFER X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE; HANDPIECE, DIRECT DRIVE, AC-POWERED
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Catalog Number A100400000000 |
Device Problems
Defective Device (2588); 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 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.
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Event Description
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In this event it was reported that a x-smart plus contra angle won't hold files; no injury resulted.
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Manufacturer Narrative
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This device can be repair by replacing the cartridge, head cap, washer, and retainer.
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Search Alerts/Recalls
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