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Catalog Number V040393025030 |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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There has been a previous report with the same product 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 paste fillers of a certain lot are separating.No injury reported.The outcome of the event is unknown as of this mdr evaluation.
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Manufacturer Narrative
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The involved paste fillers that have broken during use have not been returned and cannot be analyzed.Nothing unusual to report was found during dhrs review (batches #1455636, #1478554 and #1477871).The unused paste fillers 25mm n°2 returned have been measured and have been found in compliance with specifications.For information, no mechanical test is applicable regarding this product.Root causes are not identified.We will track this kind of event and monitor the trend.Multiple unsuccessful attempts were made to obtain the patient outcome.
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Search Alerts/Recalls
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