Catalog Number 1804-110 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Code Available (3191)
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Event Date 04/05/2017 |
Event Type
Injury
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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 3012447612-2017-00011 thru 3012447612-2017-00018.
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Event Description
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It was reported that two constructs at the l4-5 and l5-s1 levels failed to lock, resulting in the disc space collapsing 7 weeks after the constructs were implanted.A successful revision surgery was performed and the constructs were removed and competitive standalone anterior devices were placed.This is report six of eight 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 strut was examined.There were visual indications that the strut was installed, but not locked into place within the plate.There were no signs of damage on the strut.The strut was mechanically assembled with the mating pieces and found to lock into place as expected.There were no device malfunctions detected.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain sufficient instructions regarding device assembly, including strut locking.
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Search Alerts/Recalls
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