K2M, INC. STRAIGHT DEFORMITY ROD, HEX; SIZE Ø5.5X500 MM, TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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Catalog Number 101-A55500 |
Device Problem
Migration (4003)
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Patient Problem
Tissue Breakdown (2681)
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Event Date 08/06/2016 |
Event Type
Injury
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Event Description
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A physician reported that a patient has lost correction approximately six-year post-implantation.The patient has experienced kyphosis and, "the hooks cut out of the patient's back at the top," leaving the patient with two open wounds in the thoracic area where the rods are penetrating the skin.The physician reports that the construct is still intact but not attached to the bone (the screws have migrated); revision surgery has not been scheduled.The patient is implanted with denali rods, mesa hooks, and mesa pedicle screws.This report captures the second of two denali rods.
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Manufacturer Narrative
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Device remains implanted.
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Event Description
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A physician reported that a patient has lost correction approximately six-year post-implantation.The patient has experienced kyphosis and, "the hooks cut out of the patient's back at the top," leaving the patient with two open wounds in the thoracic area where the rods are penetrating the skin.The physician reports that the construct is still intact but not attached to the bone (the screws have migrated); revision surgery has not been scheduled.The patient is implanted with denali rods, mesa hooks, and mesa pedicle screws.This report captures the second of two denali rods.
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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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Search Alerts/Recalls
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