Catalog Number 07.02010.001 |
Device Problem
Migration (4003)
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Patient Problems
Pain (1994); Deformity/ Disfigurement (2360); Insufficient Information (4580)
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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.
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Event Description
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It was reported that two closure tops migrated out of their mating iliac screws post-operatively.A revision surgery is scheduled.This is report one of four for this event.
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Manufacturer Narrative
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Corrections in b5, d4: lot number and udi number, d9, h3, and h6: patient codes.Additional information in d6b and h4.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference reports 3012447612-2023-00378.
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Event Description
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It was reported that two closure tops migrated out of their mating iliac screws post-operatively.A revision surgery was performed in which the closure tops were removed and replaced while the iliac screws remained implanted.The patient's pain and posture improved following the revision surgery.The initial construct was t-11 to ilium.This is report one of four for this event.
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Search Alerts/Recalls
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