Catalog Number 1801-503 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/30/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2017-00640 - 3012447612-2017-00642.
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Event Description
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It was reported that a strut did not successfully assemble with the two mating end plates within surgery.All three devices were removed and replaced with alternative devices.There were no reports of patient impacts associated with this event.This is report one of three for this event.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Manufacturer Narrative
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The returned endplate was evaluated.There were gouges and scuff marks on the device indicative of attempted use.During a functional check, the endplate was assembled and locked with the mating strut and endplate; there was not a device failure found.The cause is likely attributed to improper alignment of the devices or improper seating on the inserter during attempted assembly and locking.A review of the manufacturing records did not identify any issues which may have contributed to this event.
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Search Alerts/Recalls
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