MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Catalog Number 54840017545 |
Device Problem
Break (1069)
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Patient Problem
Neuropathy (1983)
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Event Type
Injury
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Manufacturer Narrative
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Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Pre-op diagnosis: imaging study indicated broken hardware, lumbar radiculopathy procedure: prior lumbar fusion, possible overlay in situ fusion with removal of hardware with possible hardware revision with reimplantation of hardware l3-s1 level implanted: l4-5 it was reported that on an unknown date patient had a 4 screw construct installed.Post-op, the left l4 screw and right l5 screw were each broken completely in half about midway down the screw.Only the screw shank part attached to the tulip was able to be removed, leaving the broken distal portions of the shanks still lodged within the vertebral bodies.Patient complications were reported as unknown.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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