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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Cancer, Other (1760); Impotence (1925); Incontinence (1928); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Stenosis (2263); Urinary Frequency (2275); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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(b)(4).
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Manufacturer Narrative
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(b)(4).
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Event Description
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Patient initials: (b)(6).Gender: male.Surgery date: (b)(6) 2010.It was reported that the patient underwent a tlif at l4-5 with interbody cage and posterolateral fusion at l4-s1.Rhbmp-2 was packed in the interbody cage, placed in the disc space anterior to the cage, and along the transverse processes of l4-s1.Sometime postop, the patient reportedly experienced pain in his lower back, radiating to his legs.The patient has also experienced impotence and incontinence.
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Manufacturer Narrative
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(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.
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Manufacturer Narrative
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Updated information: history of left mid anterior rib pain.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Medical record review attached.
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Manufacturer Narrative
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(b)(6) (b)(4).
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Event Description
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Per medical records it was reported that on (b)(6) 2015 the patient was presented for office visit with low back pain.He describes the pain as an ache, burning and throbbing.Assessments: postlaminectomy syndrome of lumbar region, lumbosacral spondylosis without myelopathy, radiculitis, lumbago, (b)(6) 2015 the patient was presented for office visit with low back pain.Location of pain is middle back, lower back and legs.Assessment: postlaminectomy syndrome of lumbar region; radiculitis; lumbosacral spondylosis without myelopathy; lumbago; (b)(6) 2015 the patient was presented for office visit with low back pain.Assessments: lumbago; lumbosacral spondylosis; postlaminectomy syndrome; radiculitis.Psych analysis: insomnia (b)(6) 2015 the patient was presented for office visit low back pain.Musculoskeletal analysis: positive for back pain.Assessments: lumbago; lumbosacral spondylosis; postlaminectomy syndrome, radiculitis.
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Manufacturer Narrative
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Image review: (b)(6) 2012 ct chest no comment (b)(6) 2012 nuc med thyroid no comment, (b)(6) 2012 us thyroid no comment thyroid mass by report (b)(6) 2013 ct chest dorsal column stimulator now present, lead is dorsal (b)(6) 2013 ct abdomen/pelvis instrumentation present l4-s1 with l 4-5 interbody graft.Possile l l4 pedicle breach laterally with screw.Solid bony fusion appears present with multilevel severe neuro-foraminal narrowing, l l-45, l5-s1, and right l5-s1 with bony central canal stenosis additionally.Imaging performed for renal mass, l kidney upper pole mass noted, this was eventually resected.On (b)(6) 2013 nm bone imaging arthropathy by report (b)(6) 2013 cxr no comment (b)(6) 2013 cxr no comment (b)(6) 2013 cxr no comment (b)(6) 2013 x ray abdomen no comment (b)(6) 2013 cxr no comment (b)(6) 2013 ct chest (b)(6) 2013 ct abdomen/pelvis similar appearance of spinal hardware/fusion to previous ct, imaging performed s/p l nephrectomy for questionable renal mass.Medical details not provided in write up (b)(6) 2013 ct chest (b)(6) 2014 ct chest by report imaging performed for lung nodule stable.Impression: development of severe bilateral bony foraminal stenosis s/p l4-s1 fusion, eventually requiring placement of dcs.Complicating factors include development of renal mass and surgery, medical records for surgical approach/ pathology not available.Unclear relation of impotence/incontinence to this kidney surgery.Root cause : surgical technique.
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Manufacturer Narrative
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Per the image review, the findings are as follows: (b)(6) 2011 stress echocardiogram no spinal anatomy imaged (b)(6) 2008 right shoulder series external rotation view shows severe arthritis of the ac joint.Glenohumeral joint appears normal.Sub glenoid space appears normal.Bone is of normal density.(b)(6) 2008 right shoulder mri no spinal anatomy imaged.Overall rotator cuff appears intact without retractions.Ac arthritis is again noted with small effusion.Some irregularities and increased spinal within the undersurface of the supraspinatus tendon.(b)(6) 2009 lumbar mri stir, t1 and t2 images reviewed.Severe disc collapse with kyphosis is noted from l1 to l3 with bulging discs.Bone on bone changes are also noted at l5.High-grade stenosis is suspected on sagittal views at l5 and seen on lateral views at l4 and l5 both centrally and foraminal.Disc space narrowing with osteophytes and facet arthritis are equally at fault.(b)(6) 2009 lumbar series verify the deformities noted in mri.Collapse of the l1 and l2 discs contribute to focal kyphosis.Similar bone on bone disc collapse is noted at l5 all affecting the sagittal lordosis.Limited mobility is seen on dynamic views.Virtually no movement is seen rom l1 to l3 or at l5/s1.(b)(6) 2010 chest x-rays bilateral hilar prominence noted.Normal ribs, clavicles and shoulders, normal cardiac and pulmonary shadows.Lateral view shows flattening of the normal thoracic kyphosis.(b)(6) 2010 thoracic ct no abnormalities are seen of the cardiac or pulmonary tissue beyond the already mentioned hilar vasculature.Advanced costovertebral arthritis is noted through the mid spine.No hnp is appreciated.(b)(6) 2010 pet scan full body pet scan shows advanced degenerative spine in the lumbar area the area is not well seen.No clear evidence of tumor is appreciated.(b)(6) 2010 lower extremity venous us no spinal anatomy imaged (b)(6) 2010 lumbar mri stir, t1 and t2 images reviewed.Severe disc collapse with kyphosis is noted from l1 to l3 with bulging discs.Bone on bone changes are also noted at l5.High-grade stenosis is suspected on sagittal views at l5 and seen on lateral views at l4 and l5 both central and foraminal.Disc space narrowing with osteophytes and facet arthritis are equally at fault.This spine is presurgical.(b)(6) 2010 thoracic ct axial views from the lung apices to the mid lumbar area are shown with pulmonary reconstructions.No tumor is noted.Mild degenerative changes are seen in the costo-vertebral thoracic joints.Moderate arthritis is seen throughout the lumbar spine with canal narrowing and borderline stenosis in the upper lumbar spine.The more severe stenosis at l4 and l5 is not imaged in this study.(b)(6) 2010 lumbar series verify the deformities noted in mri.Collapse of the l1 and l2 discs contribute to focal kyphosis.Similar bone on bone disc collapse is noted at l5 all affecting the sagittal lordosis.Limited mobility is seen on dynamic views.Virtually no movement is seen rom l1 to l3 or at l5/s1.Chest x-ray prominence of hilar vasculature is now seen bilaterally, more extensive on the right.No effusions, infiltrates are seen, cardiac shadow, diaphragms, and bony architecture appear normal.Lateral view shows flattening of the thoracic kyphosis with moderate degenerative changes.(b)(6) 2010 lumbar series single lateral cross table lateral view shows initial localizing probe at the level of the s1 pedicle.Subsequent lateral shows pedicle screws in l4, l5 and s1 and cerebellar retractors in position.(b)(6) 2011 lumbar series interval placement of fusion construct with interbody spacer at l4, pedicle screws at l4, l5 and s1.Decompressive laminectomy has been performed from l4/5 to the sacrum.(b)(6) 2011 lumbar x-ray fusion construct with interbody spacer at l4, pedicle screws at l4, l5 and s1 is again seen.Interval thickening of fusion bone within the l4 disc space and posterolaterally is noted since (b)(6).Decompressive laminectomy has been performed from l4/5 to the sacrum.(b)(6) 2011 thoracic ct axial views from the lung apices to the mid lumbar area are shown with pulmonary reconstructions.No tumor is noted.Mild degenerative changes are seen in the rib and vertebral body articulations along transverse processes and lateral vertebral bodies.Moderate arthritis is seen throughout the lumbar spine with canal narrowing and borderline stenosis in the upper lumbar spine.The more severe stenosis at l4 and l5 is not imaged in this study.(b)(6) 2011 lumbar series fusion construct with interbody spacer at l4, pedicle screws at l4, l5 and s1 is again seen.Interval thickening of fusion bone within the l4 disc space and posterolaterally is noted.Decompressive laminectomy has been performed from l4/5 to the sacrum.True fusion cannot be verified on these x-ray films.(b)(6) 2011 lumbar x-rays fusion construct with interbody spacer at l4, pedicle screws at l4, l5 and s1 is again seen.Interval thickening of fusion bone within the l4 disc space and posterolaterally is noted.Decompressive laminectomy has been performed from l4/5 to the sacrum.True fusion cannot be verified on these x-ray films.(b)(6) 2011 lumbar ct axial views show construct from l4 to s1.Posterolateral fusion is present across the l5/s1 junction.At l4/5 the interbody fusion with capstone appears solidly bridged.Some heterotopic bone is seen along the insertion track of the left l4/5 level.The degree of nerve compression looks to be minimal but cannot be accurately assessed on this non-contrasted study.(b)(6) 2011 lateral sacrum positioning view taken fluoroscopically during caudal epidural injection.25-gauge needle is seen in the caudal foramen.(b)(6) 2012 lumbar x-rays fusion construct with interbody spacer at l4, pedicle screws at l4, l5 and s1 is again seen.Decompressive laminectomy has been performed from l4/5 to the sacrum.This fluoroscopic view was taken during l4 transforaminal epidural injections as 25 gauge needles are positioned outside both l4 foramen.(b)(6) 2012 thoracolumbar fluoroscopy during scs trial multiple images are provided.1) placement of epidural touhy needles within the l1/2 interspace posteriorly and into the epidural space; 2) placement of two percutaneous leads in midline with upper lead at the t8/9 disc level; 3) positioning with slight splaying of left sided lead laterally.Both leads have been pulled back about two contacts; 4) final positioning film with leads more parallel, pulled back to the level of the t9 superior endplate.(b)(6) 2012 barium swallow multiple films taken during barium swallow procedure showing contrast within the esophagus and stomach.No spinal anatomy is effectively imaged.(b)(6) 2013 ultrasound head/neck thyroid nodule is visualized in the left lower pole.No spinal anatomy is imaged (b)(6) 2014 ultrasound head/neck thyroid nodule is visualized in the left lower pole.No spinal anatomy is imaged (b)(6) 2014 lumbar series fusion construct with interbody spacer at l4, pedicle screws at l4, l5 and s1 is again seen.Decompressive laminectomy has been performed from l4/5 to the sacrum.Interval placement of spinal stimulator generator is seen on the right superficial to the l3 vertebral body to the right of midline.Fusion at l5 appears completely solid; fusion at l4 cannot be verified from this study.
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