Model Number 482317580 |
Device Problems
Fracture (1260); Device Dislodged or Dislocated (2923)
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Patient Problem
Pain (1994)
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Event Date 02/06/2023 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent revision surgery to address a fractured xia 3 ilios screw at right-side s1 and a migrated rod on the left side.The patient reported experiencing low back pain and instability, and imaging identified the fracture and migration.This report is for the xia 3 ilios screw.
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Manufacturer Narrative
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H6 coding has been updated to reflect completion of the investigation.
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Event Description
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A company representative reported that a patient was revised to address a fractured xia 3 polyaxial screw at right-side s1 and a migrated mantis redux blocker at left-side s1.The patient reported experiencing low back pain and instability approximately two months post-operatively, and imaging identified the fracture and migration.This report is for the xia 3 polyaxial screw.
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Search Alerts/Recalls
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