Catalog Number S206100230200 |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problems
Injury (2348); No Code Available (3191)
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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 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 two gates drills separated during use.In this incident, the doctor discovered the tooth had deeper decay than expected, so that patient' tooth was extracted.
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Manufacturer Narrative
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Only unused product has been received from the customer.Involved product that broke during use is not available and cannot be analyzed.Nothing unusual to report was found during dhr review.Unused product has been evaluated according to iso norms and meets expectations.Root causes are not identified.We will track this kind of event and monitor the trend.
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Search Alerts/Recalls
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