• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neuropathy (1983); Weakness (2145); Stenosis (2263); Injury (2348); Neck Pain (2433); Palpitations (2467)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Other: unknown 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 returns for her pre-op visit.She has developed adjacent segment stenosis above her fusion at l3-4.She has severe stenosis at l2-3 with instability.On (b)(6) 2007 the patient presented with the following admitting diagnosis: severe spinal stenosis, l2-l3 and l1-l2.Status post l3-l4 decompression fusion with retained pedicle screw instrumentation.The patient underwent the following procedure: removal of hardware.L1-l2 and l2-l3 posterior spinal decompression.L2-l3 fusion.Musculoskeletal/neurologic examination: straight leg raising from a seated position at 90 degrees is negative.Motor is 5 out of s.Sensory is intact to light touch.Deep tendon reflexes are symmetrical.Lumbar myelogram/ct scan shows a near-complete block at l2-l3 level.This is above the previous fusion done at l3-l4.Assessment: status post lumbar decompression and fusion revision - stable postoperatively.Continue pain control and incentive spirometry q.1h.While awake.We will restart home medications as ordered.We will check labs and follow with you.Impression: stenosis, l2-l3.Retained hardware/pedicle screw instrumentation, l3-l4.Findings: at l2-l3, there was severe central lateral recess stenosis secondary to hypertrophy in the ligamentum flavurn and the facet joint.At l1-l2 level, there was a moderate degree of central lateral recess stenosis.Bilateral decompression was performed at both the li-l2 and l2-l3 levels with medial facetectomies and foraminotomies.Following 2-level lumbar decompression, posterolateral spinal fusion was performed at l2-l3 using local bone graft supplemented with bmp and fixation was obtained with nonsegmental instrumentation at the l2-l3 level using the zeiss system with a crosslink.There were no complications.A complete bilateral l2 laminectomy was performed.The l2 pedicles were exposed in order to place the pedicle screws.She had such dense bone that exposure of the pedicle had to be done in order to properly place the pedicle screws.Ligamentum flavum was removed at the l1-l2 level as a prophylactic decompression to prevent recurrence of her stenosis.All 4 screws were indicating placement within the confines of pedicles.Latera l gutters were then exposed and transverse processes at l2 and l3 were decorticated and previously harvested local bone graft supplemented with bmp was packed in lateral gutters.Two rods were the selected, bent to lordosis, and fixed with placed screws.A crosslink was then applied.Lateral x-ray was then taken to confirm restoration of normal lumbar lordosis.Fat graft was obtained from the subcutaneous tissues and placed over the dura.There were no complications on (b)(6) 2007 the patient returns for follow-up.She is a month status post l2-3 fusion.She is happy with her early result.Her back is sore but the leg pain is essentially resolved.X-rays of the lumbar spine show the fusion at l2-3 is healing nicely.There is no evidence of loosening or failure of the hardware.On (b)(6) 2007 the patient returns for follow-up.She is three months status post l2-3 posterior decompression and fusion.X-rays of the lumbar spine show the fusion at l2-3 to be coming along very nicely.There is no evidence of loosening or failure of the hardware.On (b)(6) 2008 the patient returns for follow-up.She is six months status post extension of her decompression and fusion to include the l2-3 segment.She has some residual backache.X-rays of the lumbar spine show the fusion at l2-3 to be solid.There is no evidence of loosening or failure of the hardware.On (b)(6) 2009 the patient returns for follow-up.She is status post two-level decompression and fusion from l2 to l4.She has some residual back pain.Pain radiation into her buttocks and posterior legs has developed.The symptoms are especially worse with standing and walking.She also complains of some neck and left arm pain that has been present for the past month.She has associated paresthesias but denies any weakness into the left arm.X-rays of the cervical spine show spondylosis at c4-5 and c5-6 with decreased disc height.X-rays of the lumbar spine show the two-level fusion at l2-3 and l3-4 to be solid.There is retained pedicle screw instrumentation at l2-3.There are early degenerative changes of the l4-5 disc space.On (b)(6) 2009 the patient mri of the cervical spine with and without contrast due to neck pain and left arm and shoulder pain for the past month.Spondylosis.Impression: spondylotic change of the cervical spine most significant at c4-s and c5-6 as described.Mild cord flattening without abnormal cord signal intensity.On (b)(6) 2009 the patient underwent mri of the lumbar spine with and without contrast due to post fusion surgery in 2005 and 2007.Low back pain and bilateral lower extremity pain for the past three to four months.Findings: l1-2: moderate facet arthropathy.No disc protrusion or significant canal or foramina narrowing.L2-3: laminectomy.No disc protrusion or significant canal or foraminal narrowing.L3-4: laminectomy and interbody graft.No recurrent protrusion.Slight anterolisthesis of l3 on l4.No significant foraminal compromise.L4-5: left paracentral protrusion with impingement of arthropathy and ligamentum flavum thickening with overall mild to moderate central canal narrowing.There is mild to moderate left greater than right neuroforaminal stenosis.L5-s1: disc desiccation without protrusion.Moderate facet arthropathy.No significant central canal or foraminal narrowing on (b)(6) 2009 the patient returns for follow-up of her mrls.The patient underwent cervical mri shows a right-sided disc protrusion/herniation at c4-5 with slight displacement of the spinal cord but it is not causing a great deal of compression or neural foraminal stenosis.There are some degenerative changes and disc protrusions at c5-6 and c6-7.Lumbosacral mri, with and without contrast, shows a left-sided disc herniation at l4-5 with some displacement of the l5 nerve root.On (b)(6) 2010 the patient returns for her yearly recheck.We last saw her a year ago.She continues to complain of neck and chronic back pain.Her last mri did show a left-sided disc herniation at 4-5 with displacement of the l5 nerve root.The patient underwent x-rays of the lumbar spine which shows the two-level fusion at l2-j and l3-4 to be solid.There is retained pedicle screw instrumentation at l2-l3.There is collapse of the l4-5 disc space with kyphosis.On (b)(6) 2010 the patient returns for follow-up.She is very familiar to us.She continues to complain of chronic back pain.She is status post l2-3 and l3-4 posterior decompression and fusion.She has mri evidence of disc herniation at the l4-5 level with disc placement of the l5 nerve root.Musculoskeletal-neuro examination: straight leg raising from the seated position 90 degrees, negative.Motor is 5/5.Sensory intact to light touch.Deep tendon reflexes are symmetrical.X-rays of the lumbar spine shows a 2-1level fusion, l2-3 and 3-4, solid.There is retained pedicle screw instrumentation at l2-3.There is collapse of the l4-5 disc space with kyphosis.Impression: adjacent segment degeneration and stenosis.Left-sided disc herniation l4-5 with l5 radiculopathy.On (b)(6) 2010 the patient for her pre-op visit.She has developed a kyphosis and adjacent segment instability at l4-5 status post l2-3 and l3-4 fusion.The patient underwent lumbosacral mri which shows a kyphosis at l4-5 with reactive changes of the endplates.There is facet arthropathy but not a great deal of stenosis at l4-5.The level above the two-level fusion appears relatively preserved.There is very mild facet arthropathy above the fused segments.The patient the following procedures: l4-5 anterior lumbar diskectomy/decompression.L4-5 anterior interbody fusion.Left iliac crest bone graft.Implantation peek material fusion implant single implant l4-5 interspace.Anterior instrumentation/anterior plate and screw fixation l4-s segment.Continuous emg monitoring.Per op notes, a 1-1/2 inch transverse incision was then made directly lateral over the l4-5 disk space.Through the skin incision a separate fascial incision was made over the crest.The cannula was then tamped between tables with crest cancellous graft.It was then aspirated in standard fashion, during the distraction process emgs were obtained and there was no contact with the nerve root so a retractor was placed over the distraction plugs.The lateral aspect of the disk was cleared and then a diskectomy was performed through a lateral annulotomy.The disk space was then distracted correcting the kyphosis deformity and restoring disk space height, and also decompressing the nerve roots in the nerve canals posteriorly.After preparation of the disk space, a peek material fusion implant was selected.It was filled with cancellous graft supplemented with matrix bone graft and extended in them tamped across the disk space.The implant was placed anteriorly to get maximum correction of the kyphosis deformity, and also a lordotic shape.The implant was implanted to obtain maximum correction.After placement of the implant 2 screws were placed, one at l4 and one at l5.A plate was then placed over the previously placed screws, and locking nuts were then placed, tightened, and torqued.Excellent fixation was obtained across the segment.Postoperatively there are no complications.On (b)(6) 2010 the patient returns for a follow-up.She is status post extension of her decompression and fusion to include l4-5.She is actually doing quite well.She is standing upright and has very little back pain.She complains of paresthesias in the anterior left thigh, which she says are improving.The patient underwent x-rays of the lumbar spine which shows the fusion at l4-5 is coming along very nicely.There is no evidence of loosening or failure of the hardware.The kyphotic deformity has been corrected.There is fairly good alignment of the lumbar spine.On (b)(6) 2010 the patient presented with acquired spondylolisthesis and lower back lumbar spine problem.The patient underwent x-rays of the lumbar spine which shows the l4-5 fusion is definitely solid.There is no evidence of loosening or failure of the hardware.Ros: arthralgias/joint pain (left leg) and back pain.Assessment: acquired spondylolisthesis.On (b)(6) 2011 the patient came for a follow-up of acquired spondylolisthesis.The patient complains of residual pain status post l4-5 extreme lateral interbody fusion with plate application and weakness with her left thigh.Ros: arthralgias/joint pain (left leg and left side pain) and back pain (lower back).The patient underwent x-rays of the lumbar spine which shows the l4-5 fusion is definitely solid.There is no evidence of loosening or failure of the hardware.She is now fused from l2-l5.Assessment: acquired spondylolisthesis.On (b)(6) 2012 the patient presented with the complaint of pain in right arm and right side as well as lumbar.The patient has chronic pain secondary to the multilevel fusion.Patient reports night sweats and weight loss palpitations and light-headed shortness of breath, muscle aches (bilateral knees) and back pain (lower back) weakness (bilateral knees), nervousness, sleep disturbances, and restless sleep, increased thirst and sinus pressure.The patient underwent x-rays of the lumbar spine which shows the three-level fusion is definitely solid.There is no evidence of loosening or failure of the hardware.Assessment: displacement of thoracic or lumbar intervertebral disc without myelopathy; lumbar intervertebral disc without myelopathy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5096325
MDR Text Key26480243
Report Number1030489-2015-02474
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
Report Date 08/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510400
Device Lot NumberM114006AAC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2015
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 Number1
Patient Outcome(s) Other;
Patient Weight89
-
-