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

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

Patient Problems Arthritis (1723); Fever (1858); Neuropathy (1983); Pain (1994); Weakness (2145); Stenosis (2263); Sweating (2444)

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.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.

Event Description

It was reported that on: (b)(6) 2007: the patient underwent mri cervical spine without contrast.Impression: mild disc desiccation and far lateral right focal protrusion at l3-4 on the right and also at l4-5 on the right.A far lateral extrusion-type herniation is seen on the left with moderate to severe exit foraminal encroachment and neural compression to a mild degree.Lumbar spine without contrast impression: sagittal t1 weighted images reveal normal height and alignment as well as marrow signal of the lumbar vertebrae.There is mild disc space narrowing at the l5-s1 level and early anterior osteophyte formation at t12-l1, l3-4 and l5-s1 anteriorly.The conus medullaris is normal in size, shape and signal at the t12-l1 level.The t11-12, t12-l1, l1-2, and l2-3 levels all reveal normal disc height and hydration with no herniation, central canal stenosis or exit stenosis.(b)(6) 2008: the patient underwent mri which indicated l3-l4 bilateral foraminal stenosis, central disc bulge, and mild ligamentum flavum hypertrophy.At l4-5 there was thecal sac effacement secondary to a broad based subligamentous protrusion facet arthropathy, biforaminal stenosis, and central canal narrowing.Also, at ls-s1, there was disc protrusion resulting in abutment and displacement of the nerve roots, facet arthropathy with biforaminal stenosis, and central canal narrowing.(b)(6) 2009: the patient underwent lumbosacral spine lateral view.Impression: there are transpedicular screws in the l3, l4, and l5 vertebrae.Probes are seen in the s1 vertebra.A needle tip is at the l2-3 disc space level.(b)(6) 2009: preop: 1) herniated disk l3-l4, l4-l5 and ls-s1.2) degenerative disc disease from l3 through s1.3) lumbar spinal stenosis as a result of the herniated discs from l3 through s1.Procedure: 1) decompressive laminectomy from l3 through s1.2) posterolateral fusion from l3 through s1.3) posterior interbody fusion l3-l4, l4-l5 and l5-s1.4) insertion of anterior biomechanical device x 3.Use of k2m peek anterior biomechanical cages.One cage at l3-l4.One cage was placed at l4-l5, one cage placed l5-s1.5) insertion of pedicle screw instrumentation system from l3 through s1 with the use of stryker xia 2 pedicle screw instrumentation system.6) use of local autograft.7) use of bone morphogenic protein.8.Use of microscope.9.Use of ssep emg monitoring.Perop: a 6.5 mm diameter screw was inserted with good purchase.A high speed drill was used to perform a central laminectomy through the lamina of l3-l4.Ligamentum flavum was removed at this time and was found to be redundant decompression of the spinal nerve roots was completed centrally and then carried out into the lateral recesses using a series of curets and kenison rongcurs.Medial facetectomy with removal of the posterior osteophytes had been performed resulting in lateral recess decompression.The nerve roots in the lateral recesses were adequately decompressed and this was carried out into the l3-l4 foramen where the kerrison rongeurs were used to perform foraminotomies.Cartilage was scraped from the end plates to expose bleeding subchondral bone.This was then mixed with local morselized bone graft and bone morphogenic sponge.A high speed drill was used to perform a central laminectomy through the lamina of l4-l5.Ligamentum flavum was removed at this time and was found to be redundant, the nerve roots in the lateral recesses were adequately decompressed and this was carried out into the l4-l5 foramen where the kerrison rongeurs were-used to perform foraminotomies.A high speed drill was used to perform a central laminectomy through the lamina of l5-s1.Ligamentum flavum was removed at this time and was found to be redundant.The nerve roots in the lateral recesses were adequately decompressed and this was carried out into the l5-s1 foramen where the kerrison rongeurs were used to perform foraminotomies, nerve hook was then passed into the foramen and this was adequately decompressed.A facetectomy at the l3-l4 level was performed unilaterally deroofing the exiting nerve root which was carefully protected.The thecal sac and descending nerve root were retracted carefully.Using an 11 blade bard parker scalpel an annulotomy was created.Using a series of end plates, shavers, curets and rongeurs radical diskectomy was performed at this time.Using an 11 blade bard parker scalpel an annulotomy was created.Using a series of end plates, shavers, curets and rongeurs, radical diskectomy was performed at ibis lime.Cartilage was scraped from the end plates to expose bleeding subchondral bone.This was then mixed with-local morselized bone graft and bone morphogenic carrier sponge.Next, a k2m peek cage packed with bone graft was inserted into the disk space with distraction of the disk space.The transverse processes are decorticated with high speed drill and then packed with morselized bone graft.The remaining facet joints were decorticated with a high speed drill and packed with bone graft.(b)(6) 2010: the patient underwent mri of cervical spine.Impression: reversal of normal cervical lordosis with cervicothoracic scoliosis and retrolisthesis of c5 on c6 and c6 on c7 resulting in mild ventral cord flattening and central canal stenosis c5-c6 and mild ventral cord flattening and borderline mild central canal stenosis c6-c7.Moderate to severe right proximal foraminal narrowing c5-c6 with abutment of the exiting right c6 nerve root and moderate right and moderate to severe left foraminal narrowing c6-c7 with abutment of the exiting c7 nerve roots, left greater than right.Moderate to severe right foraminal narrowing c7-ti secondary to facet arthropathy with abutment of the exiting right c8 nerve root.(b)(6) 2010: the patient underwent mri of right shoulder.Impression: intermediate grade biceps pulley pathology and anterior outlet stenosis related changes.Associated anterior interval synovitis, glenohumeral joint arthropathy, and a constricted thickened appearance of the capsule no long biceps tendon tear or active slap tear.Impingement related changes of the rotator cuff are overall mild.Status post acromioplasty without progression to a rotator cuff tear.(b)(6) 2010: the patient went for an office visit.(b)(6) 2010: the patient underwent mri of lumbar spine without contrast.Impression: status post right tlif utilizing solitary interbody cage and posterior spine fusion utilizing transpedicular instrumentation.Shallow broad-based disc displacement at l5-s1 results in mild to moderate right foraminal narrowing and gentle abutment of the exiting right l5 nerve root.No central canal stenosis.No compressive discopathy cephalad to the fusion.(b)(6) 2010: the patient went for an office visit.Per the medical records.Diagnosis: 1) degenerative disc disease of the cervical spine 2) possible right biceps tendon tear 3) broad based disc herniation at c3-4 4) right-sided foraminal stenosis at c4-5 5) left-sided foraminal stenosis at c5-6 6) broad based disc bulge at c6-7 7) status post lumbar laminectomy and fusion from l3 to s1.This was repeated at the subsequent pedicles bilaterally.All screws were stimulated with emg, found to be acceptable and x-ray in the ap and lateral projection demonstrates the hardware to be well positioned.Next, rods were contoured and placed in the rod holders of the pedicle screws, provisionally tightened and finally tightened to the manufacturer's recommended torque.(b)(6) 2010, (b)(6) 2011: the patient presented with low back and right leg pain.(b)(6) 2011: the patient presented with low back, right hip and right lower extremity pain.Impression: 1) lumbar radiculopathy.2) post laminectomy syndrome of the lumbar spine.3) osteoarthritis of the right hip.(b)(6) 2012: the patient presented with left leg and low back pain.(b)(6) 2012: the patient underwent epidural injection due to back pain.The patient tolerated the procedure were without any complication.(b)(6) 2012: the patient underwent revision of l3-s1 plif.Preop: failed fusion, loose hardware.Procedure: removal of stryker screws and placement of everest spine screws, 6.75 x 50 for the l3, l4, and l5 levels bilateral and 775 x 40 for the s1.Facetectomy at l3-4 on the left hand side.Posterolateral arthrodesis from l3 to s1 bilaterally with bone graft, novabone bacterin placement of hemovac drain.Perop: the dissection was done with a monopolar through the fascia, through the top of the spinous processes of l3, l4, l5 and s1 screws on the right and l3, l5 and s1 screws on the left.Self-retaining retractors were placed and the screws were all removed using the stryker instruments.The screws were loose especially the s1 screws bilaterally.Facetectomy was performed at l3-4 on the left hand side.An interbody cage placement was performed but because of the nerve root.Procedure for future alif was aborted.Bacterin sponges and novabone was placed in the lateral gutters from l3 to s1.The rods were placed and torqued down to specification.(b)(6) 2012: the patient underwent anterior lumbar interbody fusion at l3-4, l4-5, and l5-s1.Preop: pseudoarthrosis of l3-s1 from previous arthrodesis, posterior interbody technique with posterolateral fusion.Procedure: anterior lumbar interbody fusion at l3-4, l4-5, l5-s1, c-arm fluoroscopic guidance.Perop: the skin was infiltrated with 0.25% marcaine with epinephrine.Then utilizing #10 blades, the skin incision was made and the anterior inerbodies from l3-s1 were identified.Then utilizing a curette, pituitary and then kerrisions careful dissection was carried and the complete diskectomy was performed, at l3-4 level a #11 blade was utilized then.11mm with novabone graft material was then tamped in this disk space.(b)(6) 2012: the patient went for an office visit.(b)(6) 2012: the patient underwent x-ray of lumbar spine 2 or 3 views.Impression: grossly stably appearing postsurgical changes within the lumbosacral spine.(b)(6) 2013: the patient presented with back spasms, pain in his low back, radiating to ble, also has loss of balance.(b)(6) 2013: the patient underwent ct scan of lumbar spine without contrast.Impression: stable postsurgical findings of the lumbosacral spine.(b)(6) 2013: the patient underwent fluoroscopy at l4-5 epidural steroid injection.The patient tolerated the procedure well without any complication.(b)(6) 2013: the patient went for an office visit due to backpain.Per the medical records.Bottom right and top screws are loose but pretty good fusion.(b)(6) 2013: the patient underwent ct scan of spine lumbar without contrast.Impression: stable postsurgical changes with evidence of loosening around the tip of the right s1 pedicle screw, multilevel spondylotic and discogenic changes without significant spinal canal stenosis.Multilevel neural foraminal narrowing is seen.(b)(6) 2013: the patient went for the preop office visit.(b)(6) 2014: the patient underwent lumbar hardware removal.Preop: hardware failure.Procedure: removal of hardware re-arthrodesis from l3-s1 bilaterally with bone grafting.Perop: hardware was removed and then a leksell was used to go down to the bone at the transverse processes.Then, these were re-arthrodesed and then bone graft was placed at l3-s1, arthrodesis was done bilateral l3-s1 with a drill.(b)(6) 2014: the patient presented for wound check, weakness in lle, fevers, night sweats, drainage from incision.(b)(6) 2014: the patient presented with pain, night sweats, and occasional fevers.

• 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: 5096185
• MDR Text Key: 26489454
• Report Number: 1030489-2015-02471
• 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: 08/24/2015

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• 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: 102