Catalog Number 482365535 |
Device Problems
Material Separation (1562); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a revision surgery to address distal junction kyphosis, the surgeon noted tulip disengagements of three of the previously implanted xia uniplanar reduction screws.The screws were explanted and replaced.This report captures the second of three screws.
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Manufacturer Narrative
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H6 coding has been updated to reflect investigation conclusion.
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Event Description
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It was reported that during a revision surgery to address distal junction kyphosis, the surgeon noted tulip disengagements of three of the previously implanted xia uniplanar reduction screws.The screws were explanted and replaced.This report captures the second of three screws.
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Search Alerts/Recalls
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