MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Weakness (2145); Stenosis (2263); Discomfort (2330); Sore Throat (2396)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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.

Event Description

It was reported that on (b)(6) 2002, the patient presented for evaluation of low back pain and right leg pain with complications of numbness and weakness in his right leg.The review of systems reveled migraine headaches, depression and difficulty in urination.Physical examinations showed stiffness in his right knee which causes a limp, straight leg raising exam on the left leg is negative, the spine showed moderate decreased range of motion with mild discomfort at the extremes of mobility in all direction.The x-rays showed severe degenerative disc disease with collapse of disc space at l4-5 and moderate stenosis at l3-4.Impression: this patient presents with debilitating chronic symptoms of low back pain and right leg pain without objective neurologic deficits, but with positive straight leg rising on the right.His degenerative changes at l4-5, i believe account for his symptoms.I think that the chronic degenerative disc disease is associated with development of facet arthritis and gradual spinal stenosis as a result of this.He has some degree of stenosis at l3-4.Though it is not nearly as impressive as it is at l4-s.His primary risk factor is that he is involved in litigation.On (b)(6) 2003, the patient presented with pre-op follow-up for a lumbar decompression l3-l5 and cage placement.Exams were performed and were normal.On (b)(6) 2003, the patient was admitted with complaints of chronic back and right left pain and right leg weakness and underwent a lumbar decompression of l4 and l5 level.Impression: he appears medically stable to undergo this surgery without any further workup.The patient underwent posterior decompression at l3, 4 and 5 due to lumbar spinal stenosis at l3, 4 and 5.No patient complications were reported.On (b)(6) 2003, the patient was discharged with discharge diagnosis of lumbar spinal stenosis at l3, 4 and 5.On (b)(6) 2003, the patient presented for follow-up of his lumbar decompression with complications of back discomfort, numbness in his leg.X-rays were performed in standing ap lateral and spot lateral lumbar position and they showed no changes other than the decompression.On (b)(6) 2003, the patient presented for follow-up of his back with complications of back pain.The exam results showed that the patient had stiff back.The x-rays were done and showed a progressive collapse of the disk space at l4-5 as well as mild progression of his grade 1 spondylolisthesis.On (b)(6) 2003, the patient presented for follow up of his low back pain with numbness which went into his legs.The patient has developed instability at the level l4-5 following his decompression.The patient underwent for ap, lateral and spot lateral lumbar x-rays in addition to lateral flexion and extension views.The examination showed severe collapse of the disk space at l4-5 with grade 1 spondylolisthesis and movement on flexion and extension views at this level and posterior decompression at l3 through l5.On (b)(6) 2003, the patient presented for preoperative evaluation prior to plan l4-l5 anterior discectomy with fusion insertion of cages and percutaneous pedicle screws ad rods posteriorly.On (b)(6) 2003, the patient underwent l4-l5 anterior discectomy with fusion and l4-l5 decompression.Per op-note, a template was used to determine the size of cages to be inserted using preoperative ap and lateral x-rays.Once this had been inserted, the appropriate size rhbmp-2/acs was saturated with liquid using the recommended surgical technique, and the saturated sponges were allowed to sit for 15 minutes before they were rolled into a cylinder and carefully placed them in the appropriate size cages.After performing discectomy, a cage with the rhbmp-2/acs bone graft material inside was inserted under c-arm control.(b)(6) 2003, the patient was discharged with diagnosis of l4-l5 spinal stenosis with degenerative disk disease and spondylolisthesis and no complications.On (b)(6) 2003, the patient presented with follow-up of his anterior and posterior spinal procedure consisting of the anterior discectomy with fusion and cages at l4-5 followed with a posterior decompression at l4-5 with complications of minimal back discomfort.X-rays were reviewed and looked good.On (b)(6) 2004, the patient presented for follow-up of his anterior fusion with cages, l4-5 with complication of mild twinges of discomfort in his right leg.The x-rays were performed for standing ap, lateral and spot lateral of the lumbar spine and cages appear to be properly positioned with good restoration of the height of the l4-5 disc space.On (b)(6) 2004, the patient presented with respiratory symptoms, thick rhinorrhea, dizziness, sore throat and cough.On (b)(6) 2005, the patient presented for re-evaluation of his back with complication of lower back pain radiating into his right leg.Examination showed that the patient moved slowly and had back discomforts when he stood up from a sitting position, walks with a mild limp and had symmetrical reflexes which were diminished bilaterally.The x-ray films showed a solid fusion at l4-5.An emg study showed evidence of mild chronic l5 radiculopathy on the right in addition to a mild acute right s1 radiculopathy.On (b)(6) 2006, the patient presented for re-evaluation of his spine with complications of gait disturbance and weakness in right leg, burning discomfort from his right lower back, through his entire leg and down to the foot, pain, urinary urgency, urgency for bowel movements, swelling in his testicles.The examination results showed that the patient had an abnormal gait and limps on the right side.He had weakness of hip flexion and mild weakness of knee flexion.Also, the x-rays of lumbar spine showed a solid fusion at l4-5.The mri showed that the l4-5 area of decompression looked open and had stenosis at l4-5 due to a combination of facet hypertrophy and right-sided disk herniation.On (b)(6) 2007, the patient presented with follow-up with complications of pain in right leg and functional impairment of the right leg, knee locking in hyperextended position and had to drag the whole straight leg with each step, mild fecal incontinence and soiling as well as mild urinary difficulties.The patient underwent physical therapy.On (b)(6) 2007, the patient presented for evaluation of right knee due to complication of difficulty in walking, difficulty in stabilizing his knee by co-contracting and holding it near full extension.Also, x-rays were reviewed that showed remarkably little arthritic change and residual tunnel placements from his previous cruciate reconstruction.On (b)(6) 2007, the patient presented for a follow-up visit.On (b)(6) 2014, the patient underwent a mri of cervical spine due to neck pain with radiculopathy.Impression: there is severe multilevel degenerative disease, arthritic change and surgical change in the lumbar spine as described above.This results in multiple levels of spinal stenosis, neuroforaminal stenosis and nerve root impingement.Also, the patient underwent a mri of the lumbar spine with and without contrast due to lumbar stenosis, bilateral leg weakness and previous lumbar surgery.Findings: 1) l1-l2: disc desiccation.Mild disc height loss.Small endplate osteophytes.Mild facet arthropathy.2) l2-l3: disc desiccation.Minimal annular disc bulge.Facet arthropathy, ligamentum flavum hypertrophy, spinal stenosis.3) l3-l4: disc desiccation.Annular disc bulge with flattening of anterior thecal sac.Moderate bilateral nerve root impingement, ligamentum flavum hypertrophy, spinal stenosis.4) l4-l5: posterior spurring.Facet arthropathy.Previous posterior laminectomy.Bilateral neuroforaminal stenosis, moderate bilateral nerve root impingement.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5030625
• MDR Text Key: 24051782
• Report Number: 1030489-2015-02091
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Device Lot Number: MC111004B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 93