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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Inadequate Pain Relief (2388); Numbness (2415); Neck Pain (2433); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
(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) 2007 the patient underwent a 360 degree circumferential arthrodesis through a posterior approach at l4-5 and l5-s1 involving a transforaminal lumbar interbody arthrodesis at l4-5 with implantation of 14x26 peek biomechanical prosthetic device; open transforaminal lumbar interbody arthrodesis at l5-s1 on the right side with implantation of a 14x26 peek implant; harvesting of bone autograft from local elements; implantation of posterior segmental fixation involving of pedicle screws 6.5x50mm size screws at l4 and l5 levels and 6.5x45 mm at s1 levels followed by implantation of prebent titanium rods across the saddles of the pedicle screws; implantation of rhbmp-2 along with putty into the lateral epidural gutters as well as within the implantation devices themselves.Perop notes: with this phase of distraction completed, we took the small and medium rotating cutters and placed those into the diskectomized space and removed further diskal elements.Next, we used straight and curved reamers to remove additional diskal elements, particularly on the contralateral or left side of the patient's back.Subsequent we used the serrated curettes both up and down, and then we used the curette to finalize curetting the area in question.The curettes were removed; careful attention was paid to exploring right beneath the posterior longitudinal ligament making certain that we had removed the majority of the disk structure that was affecting his right leg.We then placed a 10 x 26 mm trial into the hole just created and noted that this was way too loose.A 12 x 26 trial was next placed and we noted again that this was too loose.A 14 x 26 trial fit nicely.The trial was removed.We then placed rhbmp-2 into a 14 x 26 spacer.The spacer device was attached to the inserter and the inserter was then passed with the spacer device into the disk space at a diagonal direction.The spacer implant was then countersunk about 2 or 3 mm below the floor of the spinal canal.A lateral image was taken and we noted excellent positioning of the spacer implant.The inserter was released.A trial that was 12 x 26 was first placed into the l5-s 1 disk space but we felt that the trial lacked some stability.The trial was removed and then a 14 x 26 mm implant trial was placed.This trial fit exceedingly well.The spacer implant that was 14.0 x 26.0 mm in size containing rhbmp-2 was then loaded onto an inserter and this spacer device was gently countersunk into the diskectomized space by about 3 or 4 mm.A lateral image was taken with the oec image intensifier.The implant was in good position, the inserter was released.We then removed the nim spine probe and tapped each channel with a 5.5 mm tap.Subsequently we placed a 6.5 x 45.0 mm pedicle screw at the right l4 site, a 6.5 x 45.0 mm pedicle screw at the right l5 site, and a 6.5 x 45.0 mm pedicle screw at the right s1 site.Each pedicle screw was then stimulated to an evoked response of greater than 25 for the right l4 screw, greater than 25 for the right l5 screw, and greater than "25 ma" or the right s1 screw.A pre bent rod was lowered over the saddles of the pedicle screws and locked into place with set screws.Initial tightening was achieved and then compressor was used to compress l5 to s1 and l4 to l5.Final tightening was achieved and a torque and counter torque wrench were used to break off the heads of the set screws.On the left side, similarly, the pedicle entry sites were located, and then the drill was used to drill a pilot hole at the left l4, left l5, and left s1 sites.The rhbmp-2 which was rolled in a bone graft sponge was placed in separate burritos lateral to the construct on both the right and left sides, this burrito bmp constructs were placed down so they were directly contiguous with the surfaces of the transverse processes.Overlying the rhbmp-2/acs matrices was placed graft putty admixed with bone autograft.On (b)(6) 2007 the patient underwent x-rays of the lumbar spine.Impressions: spinal stenosis.On (b)(6) 2007 the patient underwent x-rays of the chest.Impressions: stable mild prominence of bibasilar markings without acute infiltrate.Findings likely represent some ongoing atelectasis or mild scarring changes.On (b)(6) 2007 the patient underwent ct scan of lumbar spine.Impressions: lumbar fusion with placement of paired pedicle screws, posterior fusion material, and interbody spacers.The alignment appeared to be normal with no distinct hardware complications identified.Right laminectomy at l5.Despite hardware artifact, there appears to be persistent disc bulging within the anterior spinal canal at l4-5 and l5-s1 levels.The patient also underwent x-rays of the chest.No complication was reported.On (b)(6) 2008 the patient underwent ct scan of the lumbar spine.Impressions: at l5 there appeared to be some central disc central protrusion of disc material.A right hemilaminectomy was noted.On (b)(6) 2008 the patient was presented for office visit with low back pain going down to his right leg.Physical examinations: he had tenderness to palpation along the paraspinal region with limitation range of motion and he used cane for ambulation.Impressions: status post laminectomy, spondylosis, radiculopathy unfortunately his caudal injection did not have significant effect and he was currently exploring surgical options with his surgeon.On (b)(6) 2008 the patient underwent x-rays of the lumbar spine.No complication was reported.The patient also underwent mri of the lumbar spine.Impressions: persistent small central disc protrusion at l4-l5.Extensive granulation tissue identified anteriorly and laterally along the thecal sac at l4-l5 and l5-s1 extending into the right exit foramina.This could cause symptomatology due to irritation of the l4 and l5 nerve roots.Mild stenosis at l4-l5 created by the disc bulge, as well as hypertrophic changes of the facets.Postoperative changes suggesting resection of portions of the facet at l4 and l5 on the right.Intervertebral disc spacers at l4 and l5 with pedicle screws placed at s1, l5 and l4.Mild bulging disc at l3-4 without focal herniation or root impingement.There is minimal narrowing of spinal canal due to facet hypertrophic changes posteriorly.Ct scan impressions: stable findings of lumbar fusion of the l4-l5, and l5-s1 levels as described above.Stable persistent soft tissue attenuation seen within the central and right portions of the l4-5, and l5-s1 levels, consistent with disc bulge versus postoperative scarring.On (b)(6) 2008 the patient was presented for office visit with low back pain going to his hip.He reported pain as throbbing, pressure, aching and numbing.Impressions: status post laminectomy due to degenerative disc disease and spondylosis and he had symptoms post laminectomy, although facet involvements cannot be completely ruled out.He tried multiple conservative management with no limited pain relief.On (b)(6) 2008 the patient was presented for office visit with granulation tissue in the neuroforaminal exit zone on the right side at the l4-5 level and to some degree at the l5-s1 level.He had negative straight leg raising at 90 degrees in the sitting position, full motor power proximally and distally, and 1+ reflexes.On (b)(6) 2008 the patient underwent epidural steroid injection at caudal lumbar spine.Preoperative diagnosis: low back pain, lumbar radiculopathy, lumbar post laminectomy syndrome, lumboscaral facet joint pain.On (b)(6) 2008 the patient underwent ct scan and mri of the lumbar spine.Impressions: cumping of the nerves within the cauda equina, within the lumbar spine, likely post surgical in nature.At the l3-l4 level, there is a diffuse broad-based disc bulge with mild ventral ridging present.There is no significant foraminal stenosis.At the l4-l5 level, there is partial laminectomy with fusion present in intervertebral disc cage present.There is mild ap narrowing at this level.There is also significant soft tissue attenuation involving the right neural foramen and lateral recess, likely contacts the right l4 nerve root.At l5-s1 level, there is a diffuse disc bulge with mild ap narrowing of the central canal.There was also significant soft tissue attenuation seer within the region of the right lateral recess and neural foraminal at this level, likely contacting the right l5 nerve root.There was also post surgical in nature.On (b)(6) 2008 the patient was presented for office visit with low back pain.Diagnosis: degeneration of lumbosacral disc, low back pain, lumbar radiculopathy, post laminectomy of lumbar region.On (b)(6) 2008 the patient was presented for office visit with low back pain and radiation down his leg.Impressions: status post laminectomy and he had spondylosis and degenerative disc disease and he may not be stable with those medications and it is consistent.On (b)(6) 2008 the patient underwent lysis of adhesions with "racz" catheter and epidural steroid injection.Preoperative diagnosis: lumbosacral disc degeneration, low back pain, lumbar radiculopathy, lumbar post laminectomy syndrome.On (b)(6) 2009 the patient was presented for office visit with low back pain and buttock pain.Impressions: degenerative spondylosis, status post laminectomy and degenerative disease, low back pain with radicular symptoms.On (b)(6) 2009 the patient underwent epidural steroid injection at cervical spine.Preoperative diagnosis: cervicalgia, cervical disc degeneration, cervical radiculopathy, lumbar post laminectomy syndrome.On (b)(6) 2009 the patient underwent mri of the cervical spine.Impressions: mild to moderate multilevel degenerative disc disease.There is mild to moderate posterior disc bulge which causes moderate central canal narrowing and flattening of the cord anteriorly.Additionally there is moderate neural foraminal stenosis on the right, at these levels.Benign hemangioma in the c5-1 vertebral levels.On (b)(6) 2009 the patient underwent epidural steroid injection at cervical spine.Preoperative diagnosis: cervicalgia, cervical disc degeneration, cervical radiculopathy, lumbar post laminectomy syndrome.On (b)(6) 2009 the patient was presented for office visit with shoulder joint pain and lumbago.On (b)(6) 2009 the patient underwent mri of the cervical spine.Impressions: limited scan due to motion artifact despite repeated attempts at scanning.Multilevel degenerative disc disease and facet and uncovertebral joint hypertrophy is most pronounced at c3-4 and c4-5 levels.Disc herniation at these levels contact the cord but do not significantly deform it."moderate stenosis of the right c3-4 neural foramen.Motion artifact "limits optimal evaluation of the spinal cord.No grossly expansile lesions were seen." on (b)(6) 2009 the patient underwent mri of the lumbar spine.Impressions: limited scan due to susceptibility artifact from metallic hardware degrading the images, especially on the post-contrast sequences.Post-surgical changes seen from l4 to s1 posterior and anterior metallic fusion with possible bony fusion posteriorly at these levels.Degenerative changes are superimposed on a diffusely narrow spinal canal, predominantly due to an excess of posterior epidural fat.There was moderate canal stenosis at l3-4 level where facet hypertrophy appears most pronounced.Mild narrowing of the neural foramina.Pronounced posterior epidural fat along the left lateral aspect of the thecal sac at the l4-5 and l5-s1 level causes the thecal sac to be displaced to the right side with mild narrowing of the sac at the l4-5 level as described.Although susceptible artifact along the right pedicle screws at both these levels limits optimal evaluation, there is suggestion of a rightward asymmetric disc osteophyte complex that narrows the right neural foramina at both levels.Enhancing granulation tissue is seen along the right side and anterior aspect of the thecal sac at both levels with no definite residual or recurrent disc herniation seen.Normal signal in the visualized cones with no abnormal enhancement.Unremarkable marrow signal in the lumbar spine with no definite marrow infiltrative lesion seen.On (b)(6) 2009 the patient was presented for office visit with sever low back pain; right buttock, posterior thigh, and calf pain; status post l4-5 and l5-s1 circumferential fusion (b)(6) 2007.Assessments: post laminectomy syndrome, lumbar epidural lipomatosis.Lumbar stenosis, lumbar radiculopathy, neuropathic pain, solid arthrodesis at l4-s1.On (b)(6) 2009, (b)(6) 2010 the patient was presented for office visit with low back pain, neck pain into right arm.Diagnosis: cervicalgia, low back pain, facet joint pain lumbosacral, post laminectomy syndrome in lumbar region.On (b)(6) 2010 the patient underwent facet joint injections, medial branch block right l3-4, l4-5, l5-s1.Preoperative diagnosis: cervicalgia, cervical disc degeneration, cervical radiculopathy, lumbar post laminectomy syndrome.On (b)(6) 2010 the patient underwent sacroiliac joint block.Preoperative diagnosis: cervicalgia, cervical disc degeneration, cervical radiculopathy, lumbar post laminectomy syndrome.On (b)(6) 2010 the patient underwent transforaminal epidural steroid injection right l4-5.Preoperative diagnosis: cervicalgia, cervical disc degeneration, cervical radiculopathy, lumbar post laminectomy syndrome.On (b)(6) 2010, (b)(6) 2011, (b)(6) 2012 the patient was presented for office visit for follow up after having stimulator explanted.Diagnosis: low back pain, lumbar radiculopathy, lumbosacral facet joint pain, post laminectomy syndrome in lumbar region.On (b)(6) 2011 the patient underwent caudal lyses of adhesions with racz catheter and epidural steroid injection.Preoperative diagnosis: low back pain, lumbar radiculopathy, lumbosacral facet joint pain, lumbar post laminectomy syndrome.On (b)(6) 2011 the patient underwent following procedure: percutaneous placement of compact epidural spinal cord stimulator lead x1 under fluoroscopic guidance mode.Percutaneous placement of peripheral nerve field stimulation leads under fluoroscopic guidance.Perop notes: lumbar post laminectomy syndrome, lumbar radiculopathy, low back pain.On (b)(6) 2011 the patient underwent placement of spinal cord stimulator.Assessment: low back pain with radiculopathy, diabetes mellitus type 2, hypertension, chronic kidney disease, gout.Preoperative diagnosis: lumbar radiculopathy, low back pain, lumbar post laminectomy syndrome.Procedure performed: percutaneous placement of compact epidural spinal cord stimulator lead x1 under fluoroscopic guidance.Percutaneous placement of subcutaneous peripheral nerve field stimulator leads x2 under fluoroscopic guidance.Incision and subcutaneous placement of pulse generator.On (b)(6) 2012 the patient was presented for office visit with low back pain, diabetes, chronic kidney disease, high cholesterol, emphysema, high blood pressure, colon polyps, and left shoulder arthritis.Impressions: low back pain, diabetes mellitus, hyperlipidemia, hypertension, chronic obstructive pulmonary disease, colon polyps, left shoulder arthritis.On (b)(6) 2012 the patient underwent ct scan of the lumbar spine.Impressions: successful fluoroscopic-guided lumbar puncture for ct myelogram with injection of "15 ml of isovue-200m intrathecally".There were no complications during the procedure and the patient tolerated the procedure well.Patient was transferred to the ct suite for ct lumbar myelogram.On (b)(6) 2012 the patient underwent following procedure: explanation of epidural spinal cord stimulator lead under fluoroscopic guidance.Explanation of subcutaneous peripheral nerve field stimulation leads under fluoroscopic guidance.Explanation of subcutaneous pulse generator.Preoperative diagnosis: low back pain, lumbar radiculopathy, lumbosacral facet joint pain, lumbar post laminectomy syndrome.On (b)(6) 2012 the patient was presented for office visit with low back and bilateral back pain.He reported sexual dysfunction and depression.Diagnosis: low back pain, lumbar radiculopathy, lumbosacral facet joint pain, post laminectomy syndrome in lumbar region.
 
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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 Key5164758
MDR Text Key28914989
Report Number1030489-2015-02755
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 09/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/01/2009
Device Catalogue Number7510800
Device Lot NumberM110605AAJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/21/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/24/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight115
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