It was reported that on (b)(6) 2010 the patient was admitted to the facility where the patient underwent spine fusion surgery using rhbmp2 on the lumbar region of her spine from vertebrae l3 to l4.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space, transverse processes and facet joints).Post-op, patient reportedly had progressively increasing lower back and radicular pain into her lower extremities.Severe pain led to a revision surgeries, on (b)(6) 2011, and (b)(6) 2012.A fourth revision has been discussed.Patient "continues to experience chronic mid and low back pain, with pain radiating down into her hips and legs, constant numbness in her right leg, swelling in her legs and feet, muscle spasms, and numbness and tingling throughout her body." patient had "difficulty sitting, standing, and walking, and requires use of a cane for assistance in ambulation." patient also suffers from "bowel issues.".
|