Catalog Number A002222100100 |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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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.This report is for the sixth device.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.
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Event Description
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In this event it was reported that six lentulos separated involving four separate patients; the event outcomes is unknown as of this mdr evaluation.
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Manufacturer Narrative
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Additional information was received indicating there was no injury to the patient.Involved lentulo peeso reamers are actually broken in the active part or at the base of the active part.No material defect was found during analysis of the rupture patterns.No unused product is available for evaluation.The batch number is unknown, dhr cannot be reviewed.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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