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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 7510200 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Headache (1880); Muscle Spasm(s) (1966); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Scarring (2061); Weakness (2145); Burning Sensation (2146); Hernia (2240); Stenosis (2263); Numbness (2415); Irritability (2421); Sleep Dysfunction (2517)
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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 spine fusion surgery at l4 to l5 using rhbmp-2/acs.The patient's post-operative period has been marked by increasingly severe pain and numbness in his legs secondary to narrowing of the spinal canal at the l4 to l5 level and impingement of the left l5 nerve root.The patient developed pain that radiates into his lower extremities.Patient developed numbness and burning down through his 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)(6) (b)(4).
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Event Description
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Per medical records it was reported that on (b)(6) 2008: patient presented for follow-up on increasing back pain spreading into the left buttock.(b)(6) 2009: patient underwent mri lumbar spine.Impression: 1.Large extruded 4th lumbar intervertebral disc centrally.2.Degeneration of the 3rd and 4th lumbar intervertebral disc.(b)(6) 2009: patient presented for follow up for escalating back pain after the patient's car went into the ditch the weekend prior to appointment.(b)(6) 2009: patient underwent lumbar spine, 5 views.Impression: no unusual findings.(b)(6) 2009: the patient underwent intra-operative portable lumbar spine x-rays.Impression: no intraoperative complications are seen on portable fluoroscopic images.(b)(6) 2009: the patient underwent x-rays of the lumbar spine post spinal fusion.Impression: an overlapping bracing device is present, which limits evaluation; there appeared to be pedicle screws at the l4 and l5 vertebral bodies, consistent with posterior fusion; bone graft material is seen on the right and on the left at the l4-5 level; there appears to be a looped drain which has its tip over the posterior aspect of the l4-5 spinous processes.(b)(6) 2009: the patient underwent x-rays of the lumbar spine status post fusion six weeks ago.Impression: postsurgical changes at l4 and l5, otherwise, normal lumbar spine.(b)(6) 2009: the patient underwent x-rays of lumbar spine.Impression: post surgical changes at l4-5, otherwise normal lumbar spine.(b)(6) 2009: the patient underwent x-rays of lumbar spine due to back pain and radiculopathy.Impression: there has been fusion at the l4-5 disk; alignment otherwise unremarkable; no new abnormalities seen.(b)(6) 2009: patient presented for follow-up on increasing back pain radiating into left lateral thigh, going down to his knee.(b)(6) 2010 patient presented for back pain with spasms going down the right leg.(b)(6) 2011 patient presented due to chronic back pain.(b)(6) 2011 patient underwent ct scan of lumbar spine due to the lbp, p/o pseudoarthroses.(b)(6) 2011 the patient underwent mri-brain without cont.Essentially: negative mri examination of the brain.Paranasal sinus disease.The possibility of acute maxillary sinusitis should be considered.(b)(6) 2011: the patient underwent ct of lumbar spine due to back pain.Impression: 1.At l4-5, there are no findings of pseudoarthrosis; there is posterior fusion with bilateral transpedicular screws and associated left paramidline intervertebral fusion plug which demonstrates findings of osseous incorporation; the right l4-5 facets are fused with findings of callous formation and obliteration of this articular margin.2.There is lateral recess narrowing at l2-3 and l3-4 secondary to broad-based disc bulges.(b)(6) 2011: mri of lumbar spine with and without contrast.Impression: 1.Post surgical and degenerative changes noted with enhancing perineural fibrosis adjacent to lower l5 root.2.There is mild degenerative disc disease and facet arthrosis at l3-4 with bilateral neural foraminal narrowing for the l3 root, right greater than left without definite neural impingement.3.No severe central canal stenosis.(b)(6) 2011: the patient underwent x-rays of the thoracic spine due to back pain.Impression: normal thoracic spine series.He also underwent x-rays of the lumbar spine due to back pain.Impression: surgical changes of anterior and posterior fusion at l4-5 showing progressive incorporation of the anterior graft as well as progressive calcification of the posterior fusion mass.Mri of lumbar spine was also done.Impression: stable mri of the lumbar spine with postsurgical and degenerative changes with extensive scarring along the left side of the central canal at the l4-5 level surrounding the left l5 nerve root and with bilateral foraminal narrowing secondary to degenerative changes and disc bulge at the l3-4 level.(b)(6) 2011: the patient presented for back pain radiating into both legs and significant right knee pain.(b)(6) 2013 the patient was presented for office visit with back pain.(b)(6) 2014 the patient was presented for office visit with back pain and leg pain.Assessments: 1) low back pain, leg cramps,.
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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 underwent mri of lumbar spine.Impression: sagittal t2 weighted images show decreased signal in the l4-5 and l3-4 disc.There is mild broad based degenerative bulging at l3-4 and mild bugling at l2-3, but at j.A-.5 there is a large central and left disc herniation.Axial images show that this disc herniation occupies the left side of the canal and appears to displace the l4 nerve root.Impression: 1.Disc degeneration, l3-l4 and l4-l5.2.Central and left disc herniation, l4-l5 with resolved left lower extremity pain and minimal weakness.3.Back pain.4.Drug and alcohol abuse, in recovery for 14 months.5.Tobacco dependence.(b)(6) 2007 the patient presented with the following complaint: 1.Low back pain.2.Left buttock pain.(b)(6) 2007 the patient was diagnosed for: 1.Large central and left disc herniation l4-5.2.Disc degeneration l3-4 and l4-5.3.Back pain, left lower extremity radicular syndrome with very mild weakness to functional testing.4.History of drug abuse and alcohol abuse in the past currently recovering.5.Tobacco dependence.Impression: possible post concussion syndrome with short term memory issues, headaches, irritability.(b)(6) 2008, (b)(6) 2008: patient presented for follow-up on increasing back pain spreading into the left buttock.The patient was diagnosed for 1.Disc degeneration, l3-l4 and l4-l5.2.Central and left disc herniation, l4-l5 with resolved left lower extremity pain and minimal weakness.3.Back pain.4.Drug and alcohol abuse, in recovery for 14 months.5.Tobacco dependence.6.Post-concussion syndrome treated.(b)(6) 2009: the patient was diagnosed for 1.Disc degeneration, l3-l4 and l4-l5.2.Central and left disc herniation, l4-l5 with resolved left lower extremity pain and minimal weakness.3.Back pain.4.Drug and alcohol abuse, in recovery for 14 months.5.Tobacco dependence.6.Post-concussion syndrome treated.(b)(6) 2009 the patient has developed chronic low back pain.He has had intermittent left lower extremity radicular pain.His disc herniation has been evaluated several times with mri and shows some persistence of a large central disc herniation.He has significant back greater than leg pain.He has had epidural steroid injections with no improvement in his symptoms.His back pain radiates into the left lateral thigh, goes down to his knee.His back pain is constant.It is worse with extension.(b)(6) 2009: the patient presented with right knee pain.(b)(6) 2011 the patient comes back in today still complaining of quite severe mid back, low back and intermittent leg pain.(b)(6) 2012 the patient presented with on and off pain over the past few years which overall is getting worse.His pain seems to be multifactorial.He still complains of a significant amount of back pain, which also does tend to go into both of his legs.This seems to be mainly in his anterior thighs.The leg pain is intermittent, but he has constant low back pain.He also has significant pain in his right knee.He does not feel like he has pain that shoots from his back all the way to his knees but he has isolated knee pain specifically when he bends down and puts any pressure on it.This has substantially decreased in mobility.He still complains of quite significant headaches which he describes as severe every 1-2 weeks.When he gets them they are quite limiting for him.He does describe somewhat of a photophobia and an aura with them.It seems to be migrainous in nature, but he has never had a formal diagnosis of this.Once again, he feels that these headaches have persisted ever since his accident in 2007.He also feels that his right knee pain has been persistent since his accident in 2007, but they were never properly addressed due to the fact that he has always had this chronic low back issue.A workup was done in the past on his low back which did show some changes at the level above his fusion at the l3-4 level with some moderate amount of stenosis and injections were suggested in the past.Mri of lumbar spine show a disc degeneration and spondylosis at the l1-4 level which is the level above his previous fusion.This has slightly progressed from his previous imaging.An mri of the thoracic spine was done, which failed to show any significant findings.
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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) 2011, (b)(6) 2012, (b)(6) 2013 the patient was presented for office visit with back pain, lumbago and knee pain.On (b)(6) 2007 the patient underwent x rays of the cervical spine for ascertaining status post motor vehicle accident.Impression: cervical spine negative.The patient also underwent brain ct without contrast.Impression: negative cranial computed tomography.On (b)(6) 2007 the patient presented with complains of headache and back pain in the lumbar area with memory loss.The patient complained of increasing neck pain and increasing low back pain with radiation towards the right lower extremity and the knee.There is also note of radiculopathic pain on the left lower extremity.There is note of pain of the lumbar para-spinal musculature especially on the left side.Straight leg raising test was positive on the left with some spasm around the cervical para- spinal musculature.Assessment: dorsal lumbar spine.The patient also underwent x rays of the right knee due to motor vehicle accident two days prior to admission and pain in the medial right knee and the low back.Impression: normal right knee.The patient also underwent x rays of the lumbar spine.Impression: lumbar spine negative.On (b)(6) 2007 the patient underwent x rays of the chest due to chest pain.Impression: no evidence of acute cardiopulmonary process; questionable fracture of the distal right clavicle.On (b)(6) 2007, (b)(6) 2008, (b)(6) 2009, (b)(6) 2010 the patient presented with chronic back pain, anxiety/depression and knee pain.On (b)(6) 2007 the patient was diagnosed with back pain, "gerd", tobacco abuse and alcohol abuse.On (b)(6) 2007 the patient underwent mri examination of the right knee due to post traumatic pain.Impression: ligamentous and meniscal structures of the knee appeared intact.Mild chondromalacia of the patella.Minimal central joint fluid.On (b)(6) 2009 the patient underwent x rays of the chest.Impression: no acute process identified.On (b)(6) 2010 the patient underwent x rays of the abdomen due to abdominal pain.Impression: nonspecific bowel gas pattern.On (b)(6) 2011 patient presented due to chronic back pain.Diagnosis: memory loss.
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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) 2009, the patient was admitted with following preoperative diagnosis - large disk herniation , l4-5 ; central stenosis , l4-5 ; and instability.Following procedures were performed :- l4-5 left sided transpedicular decompression with complete facetectomy ; non-segmental instrumentation ; posterolateral fusion using 14 mm structural cage and iliac bone marrow aspirate.Per op notes , during the procedure , the incision was made from l4 to l5 in the midline.Pedicle screw instrumentation was placed at l4 & l5 under the fluoroscopic effect.The disk space was identified between l4 & 5 and disk material was completely removed.This space was then filled with autograft and small plaget of rh-bmp2/acs.The cage was filled and tapped into the interspace for the transforaminal lumbar interbody fusion.Then the two lordotic peek rods were placed over the pedicle screws and secured using set screws.The procedure went uneventful.On (b)(6) 2009 , patient underwent x-ray of lumbar spine.He was experiencing back pain , radiculopathy.On (b)(6) 2010, patient underwent mri lumbar spine.Impression : enhancing scar at l4-5 on the left.; ddd at l3-4 ; alignment of vertebral bodies is preserved.On (b)(6) the patient presented for mri of lumbar spine.Impression : mild ddd and facet arthrosis at l3-4 with bilateral neural foraminal narrowing for the l3 roots, right greater than left.; post surgical and degenerative changes are noted.; in severe central stenosis is seen.On (b)(6) the patient presented with pain in his right knee and thoracic spine and underwent x-ray and mri.Impression : unremarkable radiograms of the right knee.Mild broad-based disc bulge at t6-7 without significant neural compression.As per plaintiff fact sheet the rhbmp2 was administered on lumbar spine using the posterior approach currently patient complains of nerve injury; osteoarthritis; radiating pain to the legs; severe pain and persistent shooting pain in back; numbness; and concrete feeling in lower back,numbness; difficulty sleeping, burning sensation.It was reported that on: 2012 (unknown date): patient complained of back pain.
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