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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 7510400 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Cyst(s) (1800); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Weakness (2145); Burning Sensation (2146); Tingling (2171); Stenosis (2263); Numbness (2415); Ambulation Difficulties (2544); Weight Changes (2607)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a posterolateral fusion surgery at l4-s1 where rhbmp-2/acs was implanted.The patient's p ost-operative period was marked by ectopic bone growth and pain and weakness in her legs.It is reported that the patient continues to experience pain that radiates into her lower extremities.She suffers from burning pain down through her legs.
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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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(b)(4).
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Event Description
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It was reported that on, (b)(6) 2007, the patient presented for pain evaluation , urine culture , ua chemistry.(b)(6) 2010: patient underwent the left and right knee x-ray due to pain.Impression: degenerative change with joint effusion.No fracture is seen.(b)(6) 2010: patient underwent single view chest x-ray.Impression: no acure cardiopulmonary process.(b)(6) 2012: patient underwent ultrasound of pelvic due to pain, impression: large uterus.Endometrial thickness measures 1.7 cm.(b)(6) 2014: patient presented with the following admitting diagnosis: back pain and urinary symptoms.(b)(6) 2014, (b)(6) 2015: patient presented with right foot pain, abdominal pain, unsteady gait (b)(6) 2014: patient admitted in the facility for some lab tests.(b)(6) 2015: patient underwent xray of chest 2 views.Impression: no active disease in the chest.(b)(6) 2015: patient underwent ultrasound of liver.Impression: unremarkable upper abdomen ultrasound.(b)(6) 2015: patient underwent (b)(6) injection.(b)(6) 2015: patient presented with elevated liver enzymes.Follow up for (b)(6).(b)(6) 2015: patient underwent x-ray of chest 2 views.Impression: no consolidation, no failure, questionable density over right lower lung field which follow up should be obtained.(b)(6) 2015: patient underwent ultrasound for abdomen and gall bladder.Impression: unremarkable upper abdomen ultrasound.(b)(6) 2015: patient presented with possible stress fracture of right foot.(b)(6) 2015: patient presented with anxiety, hypertension , weight gain.
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Manufacturer Narrative
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(b)(4).Image review: (b)(6) 2007 lumbar mri t2 sagittal views show a grade two spondylolisthesis, isthmic type at l5 with degenerative disc disease and collapse at l5, sclerosis of the l5 and s1 bodies, foraminal stenosis of both l5 root foramina.No central stenosis is seen.Conus is seen behind l1.Synovial cysts are seen associated with the l5/s1 facets bilaterally.On (b)(6) 2007 lumbar x-rays two level spinal fusion has been performed from l4 to s1.Pedicle screws and rods are in place with partial correction of the l5 slip along with partial correction of the slip angle.Screws appear to be well positioned within the pedicles.Crosslink sits between l5 and s1 screws.On (b)(6) 2008 lumbar x-rays two level spinal fusion has been performed from l4 to s1.Pedicle screws and rods are in place with partial correction of the l5 slip along with partial correction of the slip angle.Screws appear to be well positioned within the pedicles.Crosslink sits between l5 and s1 screws.No interval change from (b)(6).On (b)(6) 2008 lumbar x-rays two level spinal fusion has been performed from l4 to s1.Pedicle screws and rods are in place with partial correction of the l5 slip along with partial correction of the slip angle.Screws appear to be well positioned within the pedicles.Crosslink sits between l5 and s1 screws.No interval change from (b)(6).On (b)(6) 2009 lumbar mri shows interval fusion with pedicle screws spanning l4 to s1.No interbody spacers or graft are appreciated.Slight reduction has been performed and l5 foramen have been decompressed.No residual stenosis is appreciated.Psuedomeningocoele is seen posterior to thecal sac at operative level.This does not compress the thecal sac.
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Event Description
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On (b)(6) 2007 the patient presented for mri of the lumbar spine due back pain, right leg pain, buttock pain, foot pain, numbness, tingling and weakness.Impression: significant spondylolisthesis and spondylolysis at the l5-s1 level.The vertebral column shows anterior spondylolisthesis and spondylolysis at the l5-s1 level, approximately grade 3.There are no pathologic characteristics of the vertebral bodies, although there is discogenic sclerosis of the l5 and s1 vertebral level.The inferior spinal cord and conus medullaris terminate at the l 1 level without pathologic signal.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that: on (b)(6) 2007, the patient presented for an office visit.On (b)(6) 2007, the patient underwent x-ray of the lumbar spine, intra-op, which displayed satisfactory spinal fusion.On (b)(6) 2007: the patient was discharged.On (b)(6) 2007 the patient presented for an office visit with back pain on (b)(6) 2007: he also underwent x-ray of the lumbosacral spine due to lumbar fusion a month ago.Impression: slightly increased sclerosis or inferior endplate of l5 some of which could be due to differences in technique between two examinations; persistent grade ii spondylolisthesis noted with evidence of posterior fusion.On (b)(6) 2009, the patient presented with low back pain and right lower extremity pain.On (b)(6) 2009, the patient underwent electromyography and nerve conduction study.Conclusions: nerve conduction velocity was within normal limits; electromyography revealed bilateral l5 radiculopathy, active, moderate in severity.On (b)(6) 2009 the patient presented for mri of lumbar spine due to left leg pain and history of prior surgery.On (b)(6) 2009 the patient presented for mri of lumbar spine due to left leg pain and history of prior surgery.It was reported that since the infuse surgery, the patient developed severe back pain, nerve damage, radiating pain in both hips, radiating pain in right leg and right foot, burning sensation in top of right foot, cancer, swelling in surgical area, mental anguish, depression.
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Event Description
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It was reported that on, (b)(6) 2012, (b)(6) 2013, : patient presented for office visit.On (b)(6) 2012: patient was admitted and underwent total abdominal hysterectomy.On (b)(6) 2012: patient was discharged.
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Event Description
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It was reported that on (b)(6) 2007 the patient presented for x-ray of lumbosacral.Impression: slightly increased solerosis of inferior endplate of l5 some of which could be due to differences in technique between the two examinations; persistent grade ii spondylolisthesis noted with evidence of posterior fusion.On (b)(6) 2007 the patient presented complaining of back and leg pain.Assessment: chronic back pain, lumbar radiculopathy.On (b)(6) 2007 the patient presented for mri due to back pain, right leg pain, buttock pain, foot pain, numbness, tingling and weakness.Impression: significant spondylolisthesis and spondylolysis at the l5-s1 level.On (b)(6) 2007 the patient presented for office visit.As per office visit notes, x-ray reveal grade 2 l5-s1 spondylolisthesis, very minimal overlying degenerative scoliosis.On (b)(6) 2007 the patient admitted into hospital due to low back and bilateral leg pain.The patient underwent decompressive lumbar laminectomy l5-s1 with fusion.The patient underwent mri scan of lumbar spine.Impression: lumbar radiculopathy; grade w l5-s1 spon dylolisthesis; hypertension; tobacco abuse.The patient underwent x-ray of portable lumbar spine.Impression: spinal fusion appears satisfactory.On (b)(6) 2007 the patient presented with perop diagnosis of l5-s1 spondylolisthesis.The patient underwent l4-5-s1 posterior lateral instrumentation with pedicle screws; l5-s1 gil laminectomy with bilateral facetectomy; posterior arthrodesis with bone morphogenic protein and autograft same incision; fluoroscopic assistance.As per op notes, after patient brought to operating room lateral fluoroscopy was used to localize the area for the skin incision.Vertical incision was made over the midline lumbar spine.Subperiosteal dissection was carried out at l4, l5 and s1.The leksell rongeur was used to remove the spinous process and lamina as well as the facet joints at l5-s1.The lateral aspect of the canal was decompressed.Ligamentum flavum was removed and the exiting nerve root was identified on the both sides.It was gradually followed out the foramina and all surrounding soft tissue was removed until the area decompressed.The nerve was seen to be markedly compressed between the l5 pedicle and the sacrum.With pedicle screws in place they were unable to distract l5 against the s1 to open up the pedicles at all.The decision was made to place screws at l4 to aide in the construct's strength and potentially take off the l5 pedicle entirely.The additional pedicle screws were placed at l4 bilaterally and further distraction was applied at l5-s1.With ongoing pressure on the pedicle screws l5-s1 was seen to gradually reduce to a grade i listhesis.Even with some reduction and separation of the pedicles, the nerve root still lay densely over the interspace and they were unable to get into the l5-s1 interspace with any of the instruments to allow anterior distraction.Decision was made to lock the construct down and not do an interbody fusion.The rods were placed as well as the caps and everything was torqued appropriately.A single cross clamp was applied.Bone morphogenic protein pledgets were placed in the lateral recess over the transverse processes with all bone from the decompression being morselized and mixed with allograft paste.This allograft and autograft mixture was placed over the bmp and transverse process.On (b)(6) 2007 the patient presented for x-ray of lumbosacral.Impression: mild scoliosis and degenerative change, postsurgical change.On (b)(6) 2007 the patient presented for office visit.On (b)(6) 2008 the patient presented for x-ray of lumbosacral.Impression: transpedicular screws again noted at the l4, l5 and s1 ver tebrae.Spondylolisthesis of l5 upon s1 is stable with degenerative endplate changes again noted at the l5/s1 level; partial lumbarization of s1 vertebrae noted unchanged.On (b)(6) 2008 the patient presented for x-ray of lumbosacral with history of low back pain.Impression: stable radiographs of the lumbar spine since the prior examination of (b)(6) 2008.On (b)(6) 2009 the patient underwent electromyography and nerve conduction study.On (b)(6) 2009 the patient presented for mri of lumbar spine.Impression: postoperative lumbar spine, l5-s1, l4-5; anterolisthesis l5-s1, flexion/extension radiographs may be helpful; spondylitic change at the l5-s1 level; l5-s1 broad-based annulus bulge, loss of intervertebral height, facet hypertrophy and neuroforaminal narrowing.On (b)(6) 2009 the patient presented for office visit.As per office visit notes, there is a little bit of foraminal stenosis on the right at l4-s1 between the lower two pedicle screws, but there is some fat around it.Patient has significant modic endplate changes at l5-s1.On (b)(6) 2010 the patient underwent fluoroscopic guided lumbar epidural steroid injection performed at l5-s1 on the right.On (b)(6) 2010 the patient presented for clinical check up.Impression: back pain, neck pain.Medications: gabapentin.
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Event Description
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It was reported that on, (b)(6) 2012: patient presented for office visit, with complaints related to her eye.(b)(6) 2012: patient presented for office visit.Patient's review of systems revealed the following: constitutional: unusual fatigue, loss of appetite, and loss of weight.Psychiatric: anxiety and depression.Assessment: menometrorrhagia, dysmenorrhea, enlarged uterus, uterine fibroids, ovarian cyst, especially on the left.(b)(6) 2013: patient presented for office visit with chief complaint of pain in jaw, swelling in head <(>&<)> neck, and underwent physical assessments.Patient had the following procedure done on her: ther/proph/diag inj sc/im (therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular).(b)(6) 2012: patient was admitted with principal diagnosis of urine tract infection and had the following procedure done on her: the r/proph/diag inj sc/im (therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular).
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