Model Number 48230000 |
Device Problems
No Apparent Adverse Event (3189); Migration (4003)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device remains implanted in patient.
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Event Description
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It was reported that 14 xia 3 titanium blockers migrated post-operatively creating what's known as an 'audible spine' where noise can be heard during movement.No revision surgery is scheduled at this time.This report represents the 9th of the 14 blockers.
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Manufacturer Narrative
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B5 was updated to reflect the new information that was received.
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Event Description
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It was initially reported that 14 xia 3 titanium blockers migrated post-operatively creating what's known as an 'audible spine' where noise can be heard during movement.Additional information indicates only 2 of the 14 devices migrated.The device captured in this report functioned as intended and did not cause or contribute to the reported event.The two migrated devices are captured in reports 3005525032-2020-00002 and 3005525032-2020-00003.This report represents the 9th of the 14 blockers.
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Search Alerts/Recalls
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