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 Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Stenosis (2263); Sleep Dysfunction (2517); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on (b)(6) 2008: the patient presented with pre-operative diagnosis of degenerative l3-4 and l4-5 disks, degenerative instability, l3-4, l4-5, low back pain, status post l5-s1 decompression and posterior spinal fusion, transforaminal lumbar interbody fusion (tlif), left-sided l3-4 and l4-5 stenosis.The patient underwent removal of posterior segmental instrumentation, l5-s1, pedicle screw system, rods, screws and end caps, left sided l3-4 and l4-5 laminectomies, left sided l3-4 and l4-5 facetectomies, left l4-5 laminectomies, facetectomies performed partially through a previously operative level, left l3 and left l4 pars interarticularis osteotomies, posterior spinal fusion, l3-l4, l5-s1, with the local bone graft, protein-1 (op-1) rh-bmp2/acs, alpha graft, allograft putty, isotis beta-tricalcium phosphate, bone matrix, posterior segmental instrumentation, l3-l4 and reinstrumentation, l5-s1 with theken pedicle screw system, transforaminal lumbar interbody fusion, l3-4 and l4-5, with local bone graft and rh-bmp2/acs, insertion of tlif interbody fusion cages, l3-4 and l4-5; concorde bullet, carbon-fiber-reinforced polymer, 10 mm, interbody fusion cage at l3-4 and theken, tlif, 10mm, peak interbody fusion cage at l4-5.Per op notes: the disk space was template to 10mm.A small piece of rh-bmp2/acs was wrapped around some local bone graft which was harvested from the posterior elements and placed in the disk space.A theken, 10mm, peak, tlip interbody fusion cage was then selected, filled with rh-bmp2/acs, tapped into position, centralized and checked with the image intensifier.The cage was in good position.The pedicle screws were also in good position.Attention was then directed towards the l3-4 level.In a similar fashion, a left sided laminectomy was performed for spinal stenosis.L3-4 facetectomy was performed.A complete through discectomy was performed in a similar fashion.The disk space was template again to a 10 mm size.A , carbon-fiber-reinforced polymer, bullet shaped, interbody fusion cage was selected.The disk space was packed anteriorly with an rh-bmp2/acs wrapped around local bone graft.Rh-bmp2/acs was packed in the bullet shaped cage and the cage was then tapped into position and centralized, and radiographs were taken.The transverse processes were then decorticated using a high-speed drill.The rods were then contoured to the patient normal lumbar lordosis, p laced into the saddles of the polyaxial screws, and then set screws were screwed into position and then torqued with a torque wrench.Bone graft composed of local bone graft, alpha graft putty, allograft putty, isotis tricalcium phosphate and op-1 rh-bmp2/acs was mixed together and then packed from the decorticated transverse processes of l3-l4 down to the existing fusion mass at l5-s1.On top of this mixture was placed matrix allograft sheets.On (b)(6) 2009: the patient underwent mri of the lumbosacral spine without contrast.Impression: status post removal of pedicle screws on the left at l3, l4, l5 and s1, fusion l3-4, l4-5 and l5-s1, minor straightening of the lumbar lordosis through the fused segment, broad based annular disk bulge at l2-3 with mild crowding of the nerves to the cauda.On (b)(6) 2009: the patient presented with chief complaint of med refill.The patient underwent radiographic examination.Impression: lumbar ddd, failed back surgery syndrome.On (b)(6) 2009: the patient diagnosed with chronic pain syndrome and disorder of the back and underwent procedure.On (b)(6) 2009: the patient presented for follow up visit.On (b)(6) 2009: the patient underwent mri lumbosacral spine with contrast.Impression: evidence of prior anterior and posterior fusion surgery extending from l3 through the sacrum.The hardware on the left appears to have been removed, the neural formina are not optimally evaluated however it is through there is some residual foraminal narrowing at l5-s1 on the left with granulation tissue in the l3-4 and l4-5 neutral foramina on the left, degenerative disc disease at l2-3 results in moderate central spinal stenosis.On (b)(6) 2009: the patient was diagnosed with sciatica, failed back surgery syndrome lumbar and degenerative disc disease.And underwent procedure.Impression: technically successful catheter directed epidurolysis left l5 and s1.Substantial reversal of detect was achieved especially in the left l5 recess and region l5, with new procedure flow.On (b)(6) 2011, (b)(6) 2010: the patient presented with chief complaint of back, hip and leg pain.On (b)(6) 2011, (b)(6) 2010, (b)(6) 2009: the patient presented with chief complaint of chronic pain.The patient underwent radiographic examination.Impression: radiculopathy failed back surgery.On (b)(6) 2011: ros revealed sleep apnea.Ros revealed: lumbar degenerative disc disease, suspected osteoarthritis of both knees.On (b)(6) 2011: the patient presented for office visit with problem of losing weight and legs getting weaker.On (b)(6) 2011, (b)(6) 2012: the patient presented with chief complaint of back, hip , leg pain.On (b)(6) 2012: the patient presented with low back pain and ble pain also patient is incapacitated by the pain and is becoming more dependent on her wheelchair.The patient was diagnosed with lumbago, displacement of lumbar intervertebral disc without myelopathy, thoracic or lumbosacral neuritis or radiculitis, unspecified, postlaminectomy syndrome of lumbar region.On (b)(6) 2013: the patient underwent mri lumbar spine at l2-3.Findings: diffuse disc bulge.The patient underwent mri thoracic spine.Ros revealed: asthma, dm, knee arthritis, abdominal pain.On (b)(6) 2013: the patient presented with sinus infection.On (b)(6) 2013, (b)(6) 2014: the patient presented with back pain, radiating into both buttocks, r>l, weakness and swelling.Ros revealed: neuro: alert and oriented x 3, appropriate speech, cn grossly intact.The patient was diagnosed with gluteal pain, sacroiliitis, lumbago, sciatica and muscles spasm.On (b)(6) 2014: the patient presented with back pain for office visit for medication refills.

• 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: 5063474
• MDR Text Key: 25280996
• Report Number: 1030489-2015-02272
• 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
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2011
• Device Catalogue Number: 7510400
• Device Lot Number: M110801AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2008
• 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 Weight: 120