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

Catalog Number 7510800

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

Patient Problems Neuropathy (1983); Rash (2033); Weakness (2145); Stenosis (2263); Injury (2348); Neck Pain (2433); Neck Stiffness (2434)

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) 2009: the patient underwent mri.Impression: post discectomy disc degeneration.On (b)(6) 2009: the patient presented with muscle pain, muscle cramps, joint stiffness, joint swelling, joint pain and difficulty walking.On (b)(6) 2009: the patient was diagnosed with pain and paresthesias down the anterior aspect of right leg.On (b)(6) 2009: the patient presented with the following pre-op diagnosis: degenerative disk disease and persistent l5-s1 radiculopathy, right lower extremity, and chronic low back pain secondary to degenerative disk disease, l4-5, l5-s1, status post laminectomy.The patient underwent: 1.Decompression, l5-s1, right.2.Minimally invasive lateral mass and facet fusion, l4 to the sacrum, with allograft, autograft, and rh-bmp2/acs.3.Posterior spinal stabilization with pedicle screws, l4 to the sacrum, bilaterally.Per-op: initially, a fairly extensive decompression was done laterally at the l5-s1 on the right side.Adequate decompression and removal of a portion of the facet on the right side at the lumbosacral level was followed, the facet at l5-s1 and l4-5 was decorticated and the lateral portion of the sacrum and the transverse process of l1 and l4 were decorticated.Pedicle screw placement was then initiated initially in the sacrum where a 6.5, 40 mm length screw was placed on the right side initially followed by appropriate screws, 6.5, 50 mm length in l5 and a 45 mm length screw in l4.Each hole was then placed with paste and bone graft was placed laterally using a strip of rh-bmp2/acs as well as cortical cancellous allograft and autograft.Once this was done, the screws of appropriate length, 6.5 x 40 for the sacrum, 6.5 x 50 for l5, and 5.5 for l4.A similar procedure was then done on the left side.A 60 mm rod was placed from the sacrum to l4.The l5-s1 area on the right side was distracted slightly.Rh-bmp2/acs was placed in the facet joint and the rod tightened to further decompress the right side at the foramen.Additional bone was placed then laterals to the screw and rod construct and somewhat posteriorly on the left side where the facet joint and posterior fusion could be done with a posterolateral mass fusion.Musculoskeletal cancellous chips were used.No patient complications were reported.The patient was discharged on (b)(6) 2009.(b)(6) 2009: the patient came for a post-operative visit.(b)(6) 2010: the patient presented for a follow up.(b)(6) 2009: the patient came for a post-operative visit.(b)(6) 2010: the patient presented for a follow up.Assessment: injury right knee.Lumbago.Status, lumbosacral arthrodesis.(b)(6) 2010: the patient presented for a follow up.(b)(6) 2010: the patient came for a follow up.(b)(6) 2010: the patient presented with back pain.Assessment: lumbago.Status, lumbosacral arthrodesis.(b)(6) 2011: the patient presented with neck pain.(b)(6) 2011: the patient presented with low back pain.The patient underwent x-ray of lumbar spine.Impression: 1.Status post posterior fusion l4 to sj with rod and pedicle screw fixation, (b)(6) 2009.2.Probable nonunion of fusion.3.Failed back surgery syndrome.4.Non-alcoholic steatohepatitis.(b)(6) 2011: the patient underwent mri and ct of lumbar spine.Assessment: lumbar spondylosis with chronic low back pain status post lumbar fusion.P.O.Change posterior rod and screw fixation l4-s1.No evidence of hardware failure.The central canal and neural foramen are patent.There is mild narrowing of the right l5-s1 neural foramen.A solid fusion mass is not identified along the posterior elements.Impression: l4-s1 posterior instrumented fusion.No spinal canal or neural foraminal stenosis.Likely small amount of granulation tissue about traversing right s1 nerve root at lateral recess.No focal disc protrusion.No nerve root clumping to suggest arachnoiditis.(b)(6) 2011: the patient presented for a follow up.Assessment: lumbago.Status, lumbosacral arthrodesis.(b)(6) 2011: the patient presented with back pain.Diagnoses: 1 low back pain.2 intermittent right lower extremity leg pain, question radiculopathy.3 status post l4-s1 fusion with instrumentation.(b)(6) 2011: the patient presented with pain.The patient underwent following pre-op diagnosis: lumbar spondylosis without myelopathy, status post lumbar fusion.Procedure followed: bilateral l3-4 facet joint injections under fluoroscopy.(b)(6) 2011: the patient presented for office visit.Diagnoses: low back und right lower extremity pain in the setting of previous lumbar spine surgery which constitutes for failed back surgery syndrome.(b)(6) 2011: the patient presented for a follow up.The patient underwent x-ray.Assessment: lumbago.Pain in left leg.Symptoms, disturbance of skin sensation, left leg.Status, lumbosacral arthrodesis.(b)(6) 2011: the patient underwent ct myelogram of l-spine (b)(6) 2011: the patient undergone diagnosis for chronic low back and leg pain.(b)(6) 2011: the patient presented with pre-procedure instructions for neurostimulator trial.(b)(6) 2011: the patient presented with back pain.(b)(6) 2011: the patient presented with pain.Pre-op diagnosis: failed back surgery syndrome.Procedure performed: spinal cord stimulator implant-trial.Peripheral nerve stimulator lead trial (b)(6) 2011: the patient presented with post trial implantation of spinal cord stimulation system.(b)(6) 2011: the patient presented with intractable pain.The patient underwent spinal cord stimulator epidural lead implantation and peripheral lead implantation.(b)(6) 2011: the patient presented for a follow up.(b)(6) 2011, (b)(6) 2012: the patient presented with low back pain.Diagnosis: implanted stimulator.Pruritic rash (b)(6) 2012: the patient presented with back pain.Impression: failed back surgery syndrome.Status post spinal cord stimulator implant.(b)(6) 2012: the patient presented for neck pain and headaches.The patient was diagnosed for back and bilateral lower extremity pain, markedly improved status post spinal stimulation.Progressive neck pain with some radicular left upper extremity pain.The patient underwent ct of the cervical spine without iv contrast material.Rather focal and marked degenerative changes at c5-c6, with interspace narrowing and associated hypertrophic changes that appear to result in moderate spinal and bilateral neural foraminal narrowing at this level, greater on the right.Otherwise, scattered degenerative changes the cervical spine are relatively mild andare without substantial effect as other spinal canal and neural foraminal narrowing appears to be at most minimal.(b)(6) 2012: the patient underwent ct which showed severe degenerative disk disease with both central and foraminal narrowing at c5-6.(b)(6) 2012: the patient presented with pre-procedure evaluation only, neck and left lower extremity pain.Impression: 1.Chronic neck, right shoulder, and right upper extremity pain.2.Cervical spondylosis without myelopathy.The patient underwent fluoroscopically-guidedc7-t1 interlaminar epidural steroid injection under fluoroscopy.(b)(6) 2012: the patient presented for a follow up.(b)(6) 2012: the patient presented with neck and left greater than right upper extremity pain.Assessment: mechanical neck pain due to degenerative disc and degenerative facet disease.Left cervical radiculopathy.(b)(6) 2012: the patient presented with neck and left greater than right upper extremity pain.(b)(6) 2012: the patient presented for a follow up of chronic neck pain.Impression: 1.Possible stevens-johnson syndrome with cymbalta use.2.Mechanical neck pain due to degenerative disc and degenerative facet disease.(b)(6) 2013: the patient presented with low back pain impression: mechanical neck pain due to degenerative disc and degenerative facet disease.Left cervical radiculopathy.(b)(6) 2013: the patient presented for office visit.(b)(6) 2013: the patient presented for an office visit.(b)(6) 2013: the patient presented with low back pain.(b)(6) 2013: the patient presented with neck and left greater than right upper extremity pain.Emg showed carpal tunnel syndrome.It is moderately severe on the right and mild on the left.Diagnoses: 1.Mechanical neck pain due to degenerative disk and degenerative facet disease.2.Left cervical radiculopathy.Impression: analysis and reprogramming of her medtronic spinal cord stimulator (b)(6) 2013: the patient presented for a follow up.(b)(6) 2013: the patient presented with pain and stiffness in joints, back pain, weakness in arms or legs, numbness and shooting pain in hands, arms ,legs or feet, excessive day time drowsiness, restlessness.(b)(6) 2013: the patient presented with some symptoms in the right leg which is more right anterior thigh region.She described a tingly sensation.(b)(6) 2013: the patient presented for evaluation of her obesity.(b)(6) 2013: the patient presented with hypertension and obesity.Diagnosis: class 3 obesity, hypertension, dyslipidemia, chronic back pain with l4-s1 fusion, snoring.

• 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: 5055433
• MDR Text Key: 25006784
• Report Number: 1030489-2015-02208
• 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: 08/11/2015

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
• Device Expiration Date: 07/01/2011
• Device Catalogue Number: 7510800
• Device Lot Number: M110807AAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2009
• 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: 00051 YR