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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Neuropathy (1983); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).(b)(4).Multiple products used in the event.It is known which product caused the event.Product id: 2922245, lot number: 51au, quantity: 1; product id: 2968045, lot number: 49am.Quantity: 1; product id: 2922255, lot number: 06as, quantity: 1; product id: 2153116, lot number: 75ac, quantity: 1.X-ray analysis: patient presented with ligament disease.She had an extensive fixation for l2-s1 including multilevel oblique plate and cages.Patient still had back pain at time of complaint.2-3 months post op there is no problem identified with hardware on post op x-ray.Root cause surgical technique / patient factors.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
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Event Description
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It was reported that: on (b)(6) 2015: patient was diagnosed with radiculopathy.Motor deficit- l2 to s1: 5(both left and right).Sensory deficit- left l4 and l5: incomplete.Patient was diagnosed with disc herniation at l1-l2(protruded), l4-l5(protruded), l5-s1(protruded).Disc degeneration at l1-l2, l2-l3, l3-l4, l4-l5, l5-s1.Miltilevel discopathies at l5-s1.Spinal stenosis at l4-l5(central).Spondylolisthesis at l4-l5(grade 1).Patient presented with the history of hypertension.It was reported that on an unknown date, post-op, patient complained of left and right sacroiliac joint pain.As per the doctor, it was related to the fixation (stablization) system and the plates related to probable stress from anterior/posterior construct.On (b)(6) 2016: patient presented for follow-up.On (b)(6) 2016: patient presented with right and left sensitive radiculopathy.
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Search Alerts/Recalls
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