It was reported that a patient underwent an interspinous process decompression at levels l3-l4, l4-l5.Five months post-op, the patient reported progressive low back and right posterior thigh and leg pain for five months.The mri revealed progressive lumbar spondylotic changes with severe canal stenosis at l3-l4 and l4-l5 and spondylolisthesis at l4-l5.The patient underwent a removal at l3-l4 and l4-l5 and decompressive laminectomies and foraminotomies with in situ fusion at l3-l4 and l3-l5.The interspinous spacer devices were explanted on (b)(6) 2014.The investigator noted this event was serious with a severity of moderate.The relationship to the device was not related.The outcome of the event is resolved.
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