Catalog Number A000824000200 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problems
No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
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Event Type
malfunction
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Manufacturer Narrative
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There has been a previous report received where a breakage issue 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 21 cfr 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 broken gates ra drill bit remained in a patient's month but no patient injury resulted.
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Manufacturer Narrative
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Additional information was received that the broken piece was retrieved from the patient's mouth.Multiple unsuccessful attempts were made to obtain the device for evaluation.The lot number 1402001217 doesn't exist in maillefer's database.No evaluation can be performed.
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Search Alerts/Recalls
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