Neither the device nor films of applicable imaging studies were 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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It was reported that the patient was diagnosed with spinal canal stenosis; and underwent oblique lumbar interbody fusion and posterior pedicle screw fixation at l4-l5.On an unknown date, post-op, the lower end plate of l4 fractured due to patient's slight carelessness, and the implanted screw at right of l5 loosened.Allegedly, the patient also got paralyzed due to this event.Hence, an emergency revision surgery was performed, in which the loosened screw was replaced and additional screw insertion was performed on both sides of l3.Fixation was performed again.
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