Outcomes to adverse event? pyogenic spondylitis.This part is not approved for market in the us; however, a like device with part# 54840006555, 510(k): k091974 and upi #: (b)(4) was cleared in the united states.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 on (b)(6) 2019, the patient underwent posterolateral spinal fusion (psf) at l2-l5 and posterior lumbar interbody fusion (plif) at l3-l5.On an unknown date, post-op, patient suffered with pain in the lower back and pyogenic spondylitis was reported at l5.The screws implanted on both sides of l5 loosened.Hence, on (b)(6) 2019, the patient underwent a revision surgery; in which, the rod along with the loosened screws at l5 were removed.Additional screw insertion was performed at s1 and s2ai, and fixation range was extended.Currently, the patient is in bad condition and is in icu.
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