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

Catalog Number 7510200

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

Patient Problems Dysphagia/ Odynophagia (1815); Inflammation (1932); Neuropathy (1983); Pain (1994); Tingling (2171); Stenosis (2263); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that on (b)(6) 2009, the patient presented with l5-s1 degenerative disc disease and underwent following procedures: l5-s1 anterior arthrodesis.Placement of l5-s1 intervertebral prosthesis.Anterior instrumentation with axial rod at l5-s1.Harvest of morselized local bone graft.Posterior non segmental instrumentation with facet screws at l5-s1.Posterior facet fusion.Per op-notes, ".The bone from the sacrum was harvested and mixed with human cancellous bone chips, bone marrow aspirated from the sacrum and rhbmp-2.The disk at l5-s1 was centrally evacuated with angled cutters and whisks.All but 4cc of bone graft was packed into the disk space.Attention was then turned to posterior instrumented fusion.On "(b)(6) 2009, the patient had ct of lumbar spine.Impression: scoliosis with secondary degenerative changes.Axial fusion at lumbosacral junction doesn't appear unusual.Left pedicle fusion at l3-4.(on b)(6) 2009, the patient presented for follow up.Impression: the patient had developed what was a superficially infection of her sacral wound.On (b)(6) 2009, the patient visited for follow up.On (b)(6) 2009, the patient visited facility for medicine refill and post-op follow up.Ct of the pelvis on (b)(6) 2009 showed good position of the axial and facet screws.On (b)(6) 2009, the patient presented with history of degenerative disc disease and had undergone x-ray lumbar spine.Impression: stable fusion with axial lift l5-s1 with unilateral pedicle screws through l3-4 with advanced djd at l3-4 disk space.On (b)(6) 2009, the patient appeared for follow up and review of her reports.On (b)(6) 2009, the patient presented for follow up.She had difficulty swallowing for approximately six months.Impression: lumbar disc disease, status post lumbar laminectomy, discectomy and fusion, dysphagia , history of (b)(6).On (b)(6) 2009, the patient visited for follow up.Impression: the patient appeared to have fused the l5-s1 level.The patient continues to have pain that may be secondary to her lesion or inflammatory changes around the low lumbar spine.On (b)(6) 2009, the patient appeared for follow up visit.Impression: the patient with myofascial syndrome and lumbar arthrodesis at l5-s1.On (b)(6) 2010, the patient made a follow up visit.Impression: lumbar disk disease; peripheral neuropathy.On (b)(6) 2010, the patient presented for follow up visit.Impression: left sciatica as well as left knee pain.In addition to left lumbar radicular pain, she had left knee pain from degenerative disk disease.On (b)(6) 2010, the patient had mri of left knee.Impression: grade 3 <(>&<)> 4 chondromalacia patella adjacent to the median ridge.The patient also underwent mri lumbar spine.Impression: extensive post-op and degenerative changes are present.On (b)(6) 2010, the patient presented with electromyography report.Impression: chronic l4 radiculitis on the right.On (b)(6) 2010, the patient had lumbar myofascial syndrome.On (b)(6) 2010, the patient presented for follow up.Impression: continued to have low back pain secondary to l3-4 spondylosis, left l3 radiculopathy.On (b)(6) 2010, the patient presented for follow up visit complaining low back pain, numbness and tingling sensation of both legs.The patient had x-rays and mri.Mri showed severe stenosis at l3-4, l4-5 and l5-s1.The x-rays showed severe degenerative changes at l3-4, l4-5 and l5-s1 levels.On (b)(6) 2010, the patient presented for follow up visit complaining low back pain.The patient had physical examination.On (b)(6) 2010, the patient presented for lumbar spine three views.Impression: post fusion changes at l3-4 and l5-s1.On (b)(6) 2010, the mri of lumbar spine indicated moderate spinal stenosis at l3-4, l4-5 and l5-s1.Moderate compression of the right l5 nerve root in the l5-s1 neural foramen due to moderate lateral disc bulging.Disc bulging at l1-2 and l2-3 without spinal stenosis.Disc material coming into contact with right l4 nerve root in the right l4-5 neural foramen due to moderate lateral disc herniation.On (b)(6) 2010, the patient underwent imaging review myocardial perfusion spect.Impression: no evidence of stress induced myocardial ischemia.On (b)(6) 2010, the patient presented for pre-operative visit.On (b)(6) 2010, the patient was admitted with diagnoses of: l3-4, l4-5 and l5-s1 disk herniation, central canal stenosis and foraminal stenosis.Status post l3-4 posterolateral fusion and pedicle screw fixation on the left side only.Status post l5-s1 facet screws and attempted facet fixation.The patient underwent following procedure: l3-4, l4-5 <(>&<)> l5-s1 laminectomy, discectomy, foraminotomy , medial facetectomy.L3-4 <(>&<)> l5-s1 posterolateral fusion.Removal of facet screws.Right l3-4 <(>&<)> l5-s1 transpedicular internal fixation.Left l5-s1 transpedicular internal fixation.The patient underwent mri of lumbosacral spine.Impression: symptoms of lumbar radiculopathy secondary to disk herniation, facet arthropathy and thickening of the ligamentum flavum at l3-4, l4-5 <(>&<)> l5-s1 (b)(6) 2011, the patient presented for follow-up visit.The patient complaint of mild occasional low back pain that radiated to the left buttocks but not to lower extremities.On (b)(6) 2011, the patient underwent digital screening bilateral mammogram interpreted with computer aided detection.Impression: bi- rads 2: benign findings.The patient also had hip x-ray unilateral.Impression: ap and frog leg view of the right hip.No fracture or dislocation.On (b)(6) 2011, the patient presented for follow-up visit.On (b)(6) 2011, the patient presented for follow-up visit.The patient complaint of mild occasional low back pain.On (b)(6) 2012, the patient presented for follow-up visit.On (b)(6) 2012, the patient had underwent bone imaging, limited -3phase.Impression: minimal increased radiotracer uptake at the tip of the femoral component of the right hip prosthesis.This can be seen with loosening.On (b)(6) 2013, the patient underwent mri of lumbosacral spine.The scan indicated evidence of posterior fusion at the l3, l4, l5 and s1 level with wide laminectomies at these levels and transpedicular internal fixation of l3, l4, l5 and s1.There was no evidence of disc herniation or central stenosis or foraminal stenosis.There was a mild disc protrusion at l1-2 <(>&<)> l2-3 levels.On (b)(6) 2013, the patient had a history of dysphagia and underwent imaging exam.Impression: moderate to severe esophageal dysmotility.On (b)(6) 2013, the patient presented with complaint of low back pain.On (b)(6) 2013, the patient presented with foot pain and underwent x-ray examination.Impression: degenerative changes at the first metatarsal phalangeal joint.On (b)(6) 2013, the patient presented with abnormal radiologic findings, "mvc" with neck pain.The patient underwent ct cervical spine.Impression: no acute fracture or traumatic subluxation of the cervical spine.Extensive post-surgical and degenerative changes without evidence of hardware complications.The patient underwent x-ray spine.Impression: acdf c3-4 and acdf c6-7.Plates do not appear flush with the vertebral bodies.Some of the screws are not flush with the plate.Ct evaluation without contrast is recommended.On (b)(6) 2013, the patient underwent mri of the cervical spine.Impression: extensive surgical construct of the c3-7 levels as above.Radiographs could further evaluate the integrity of the construct.No recurrent spinal canal narrowing is identified, however there is mild ventral contouring of the spinal cord at c3-4 varying degrees of bilateral foraminal narrowing are present.On (b)(6) 2014, the patient presented with complaint of neck pain.The patient had musculoskeletal examination.Impression: cervical pain; cervical radiculopathy.On (b)(6) 2014, the patient presented with diagnosis of cervicalgia and cervical radiculopathy and underwent cervical facet medial branch block; 2nd level; additional level.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5594998
• MDR Text Key: 43276336
• Report Number: 1030489-2016-01146
• 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: Attorney
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110801AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: 03/23/2016
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2008
• 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 Age: 00060 YR
• Patient Weight: 78