Revision surgery was conducted (b)(6) 2020 to extend the fixation from l4/5 to l3-l5 due to adjacent segment disease.While the surgeon tried to remove the implants, the id of the polyaxial screw was stripped/crushed and could not be removed.Eventually, after a 2 hour delay and alternative instrumentation, the surgeon was able to remove the implants.The illico mis posterior fixation system was originally implanted on (b)(6) 2015 at the l4/5.
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Review of the device history records found no manufacturing, processing or design related irregularities.The implant was found to be properly manufactured and released in accordance with the device master record.An evaluation of the returned polyaxial screw contained evidence that the screw removal tool had not been completely/securely engaged.The most proximal portion of the bone screws.140 deep internal hexalobe feature had rounded and worn edges while the majority of the distal section remained crisp and sharp as manufactured.This suggests that the tulip/head of the polyaxial screw required alignment to allow for clear engagement of the screw removal tool.Once aligned, the male hex of the removal tool and the female of the bone screw would properly mate and allow for extraction.
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