Catalog Number 0206716000 |
Device Problem
Flaked (1246)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/13/2014 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure the disposable cement sculps were producing blue flakes.It was reported that the doctor was able to scrape the cement which contained the blue flakes out of the surgical site.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
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Event Description
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It was reported that during a procedure the disposable cement sculps were producing blue flakes.It was reported that the doctor was able to scrape the cement which contained the blue flakes out of the surgical site.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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A follow up report will be filed after the quality investigation has been completed.
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Manufacturer Narrative
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Even though the reported product was not available for evaluation, as it had been discarded by the customer, the reported condition of flaking can be considered confirmed based on the blue debris samples that were retrieved by the doctor and returned for evaluation.The returned blue particles resemble the material and color of the device surface.
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Search Alerts/Recalls
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