It was reported that in 2010 the patient presented with neck and back pain.The patient was scheduled for surgeries.It was reported that the patient underwent lateral lumbar interbody fusion at l1-l2, l2-l3, l4-l5 using rhbmp-2/acs with cages.Following the second surgery, the patient developed a serious infection of the surgical area, e-coli, and abscessed discs.On (b)(6) 2011, patient underwent a laminectomy at l1-l2, l4-l5 and a posterior spinal fusion at t11-l5 using rhbmp-2/acs.The patient continues to experience severe pain, both mental and physical.
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(b)(4).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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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It was reported that on (b)(6) 2011: patient presented for post-operative evaluation.On (b)(6) 2011: patient underwent physical therapy.On (b)(6) 2011: patient presented for follow up of his diabetes.Diagnoses: dm without complication type 2; chronic pancreatitis, anxiety, ddd-cervical, lumbar disc disease.On (b)(6) 2011: patient underwent cervical spine x-ray due to neck pain.Impression: congenital block vertebrae c-c6 level; interfusion and discectomy at c4-c5 and c6-c7 levels.Associated grade 1 c4-c5 spondylolisthesis demonstrating no evidence on instability.On (b)(6) 2011 the patient presented with complaints of low back, pain, scoliosis, ddd.On (b)(6) 2011 the patient presented with the following pre-op diagnosis: severe degenerative lumbar scoliosis: l1-l2, l2-l3, l3-l4, l4-l5; degenerative lumbar spondylolisthesis: l1-l2, l2-l3, l3-l4, l4-l5.The patient underwent the following procedure: stage direct lateral lumbar diskectomy, l1-l2, l2-l3, l3-l4, l4-l5; direct lateral interbody fusion using auto and allograft l1-l2, l2-l3, l3-l4, l4-l5; placement of direct lateral interbody cages l1-l2, l2-l3, l3-l4, l4-l5.Per op notes, at first, using the spinal cord monitoring position of the lumbar plexus was completely determined.The psoas was split and a lateral annulotomy was performed.At this point, the disk was sequentially dilated and the end-plates were prepared for fusion.At this point, the lateral interbody cage was placed in the disc space.Intra-op x-ray was done to check the position of the cage.Under c-arm images, jamshidi needles were placed in the lumbar pedicles at the predetermined levels.Pedicle wires were placed through the jamshidi needles.Then pedicle screws were placed on the wires.Wires were removed then.An appropriate sized rod was placed in a percutaneous fashion in a way that it passed through all of the screws extensions.At this point, the set screws were placed to secure the rod to the screws.The exact same procedure was performed on the opposite side as well.No complications were noted.On (b)(6) 2011 the patient presented with complaints of decreased mobility in adl's status post lumbar spinal fusion.The patient describes the pain as just a deep dull achy pain.Impression: gait disturbance; acute post-op pain.On (b)(6) 2011 the patient came for medical management of diabetes and other comorbidities post-op.Assessment: diabetes mellitus type ii; essential hypertension; degenerative disk disease of cervical region.
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