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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
Arthritis (1723); Bronchitis (1752); Edema (1820); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Muscle Spasm(s) (1966); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Tingling (2171); Stenosis (2263); Discomfort (2330); Depression (2361); Inadequate Pain Relief (2388); Numbness (2415); Respiratory Tract Infection (2420); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544); No Code Available (3191)
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Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2009 the patient underwent a spine fusion surgery on the lumbar region of her spine from vertebrae l4 to s1 using rhbmp-2/acs.It was reported that the patient's post-operative period has been marked by increasingly severe pain in her legs.It was reported that the patient developed pain, numbness and weakness that radiates into her lower extremities.
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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) 2009: the patient underwent posterolateral fusion l4- s1 w/bmp due to spondylolisthesis l5-s1; degenerative disk disease l5-s1; broken hardware, s1 pedicle; severe arthrosis, lumbar spine; chronic back pain, leg pain, radiculopathy.Rods; set screws; cancellous chips were also implanted.From 2004-2013: the patient was treated for back and leg pain.From 2006-2011: the patient underwent physical therapy.From 2013 to present: the patient was treated for back pain.Allegedly, after the rhbmp-2/acs surgery, injuries include, but are not limited to radiating pain to legs; back pain; pain in both hips; nerve injuries; heterotopic bone; osteoarthritis; mental anguish; difficulty walking; difficulty standing for long periods.
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Manufacturer Narrative
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Additional information.
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Event Description
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It was reported that on, on (b)(6) 2010, (b)(6) 2009, the patient underwent x-ray of lumbar spine pa and lateral.On (b)(6) 2009 the patient underwent chest x-ray pa and lateral.On (b)(6) 2015 the patient underwent 'cr spine lumbar bend 2 or 3 views'.
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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, on 1(b)(6) 2006 the patient also underwent x-rays of the lumbar spine.Impression: stable fixation with subluxation at l5/s1.On (b)(6) 2009 the patient underwent chest x-ray pa and lateral due to back pain.Impression: no acute findings.On (b)(6) 2009: the patient underwent x-rays of the lumbar spine due to low back pain.Impression: postoperative change without evidence of hardware failure; grade 2 or 3 anterolisthesis l5 on s1 again noted.On (b)(6) 2009: the patient underwent x-rays of the lumbar spine due to back pain.Impression: no evidence of postoperative complication; no fractures; otherwise unremarkable x-ray.On (b)(6) 2010: the patient presented with lip swelling and edema.Diagnosis: cellulitis of the lip and face; essential hypertension.On (b)(6) 2010: the patient underwent ct scan of the facial bones due to right sided facial pain and swelling.Impression: negative exam; no evidence of abscess or osteomyelitis.On (b)(6) 2010 the patient was presented for office visit.Impressions: obesity, anxiety, depression, hypertension, arthropathy, lumbago, neuritis, insomnia, abdominal pain.On (b)(6) 2010 impressions: obesity, anxiety, depression, hypertension, arthropathy, lumbago, neuritis, insomnia, abdominal pain, malaise and fatigue.On (b)(6) 2010: the patient underwent electromyography nerve conduction study due to shooting painful paresthesias in the right great toe, and pain in the right leg.Impression: normal motor nerve conduction velocities and latencies in the right tibial peroneal nerves; normal sensory conduction in the right superficial peroneal nerve; normal electromyogram examination.On (b)(6) 2010 impressions: obesity, anxiety, depression, hypertension, arthropathy, lumbago, neuritis, insomnia, abdominal pain.On (b)(6) 2011 the patient also reported muscle spasms in the neck.On (b)(6) 2011 the patient was presented for office visit with pain on right side of the neck and depression.On (b)(6) 2011 the patient was presented for office visit with cough, back and leg pain.Impressions: obesity, hypertension, acute uri, acute bronchitis, lumbago, neuritis and pain in limb.On (b)(6) 2012: the patient presented with diabetes follow-up.Assessment: diabetes type 2; hypertension; hyperlipidemia; diabetic neuropathy; osteoarthritis.On (b)(6) 2012 the patient was presented for office visit with cold like symptoms.Impressions: obesity, hypertension, acute uri, acute bronchitis, lumbago, neuritis and pain in limb.On (b)(6) 2013 the patient presented for follow up visit with arm pain.On (b)(6) 2013 assessment: back pain; lue pain; hip pain; anemia; ble neuropathy; obesity; hypertension.On (b)(6) 2013 the patient was presented for office visit for med refills.Assessments: shoulder pain, hip pain, numbness, tingling, anemia, neuropathy, morbid obesity, hypertension, tinea corporis, allergic rhinitis, diabetes, heavy menses.On (b)(6) 2014: the patient presented with hypertension and chronic low back pain.She was also diagnosed for anemia and heartburn.Assessment: hypertension; anemia; chronic pain syndrome; gastroesophageal reflux disease; hyperlipidemia; obesity.On (b)(6) 2014: patient presented with esophageal reflux, hypertension, upper back and chronic pain syndrome.On (b)(6) 2014: the patient presented with an office visit for medication refill.Assessment: radicular low back pain, chronic pain syndrome, hypertension, osteoarthritis and lumbar disc degeneration.On (b)(6) 2014: patient diagnosed with hypertension, depression and anxiety.On (b)(6) 2014: the patient presented with low back pain.Patient diagnosed with hip pain and diabetes.On (b)(6) 2014, (b)(6) 2015: the patient presented for an office visit with follow-up of chronic low back pain, which was stabbing.The symptoms aggravated with lifting and walking.On (b)(6) 2014the patient presented with abscess follow-up.Assessment: abscess of vulva.On (b)(6) 2014: the patient presented with abscess follow-up.Assessment: abscess of vulva.On (b)(6) 2014: the patient presented with chronic pain syndrome.On (b)(6) 2015: patient diagnosed with hypertension and chronic pain syndrome.On (b)(6) 2015 the patient underwent 'cr spine lumbar bend 2 or 3 views' due to back pain.Impression: remote l5-s1 posterior fusion; stable anterolisthesis noted involving l5 on s1.On (b)(6) 2015: the patient presented for an office visit with cough, which worsened at night.She also had complaints of hypertension and gastroesophgeal reflux disease.Patient diagnosed with upper respiratory infection and unspecified iron deficient anemia.On (b)(6) 2015: the patient presented for an office visit with cough.Assessment: anemia; cough.
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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 in 2006 the patient underwent surgery for hardware failure l5-s1; screw arthrosis, l5-s1; spondylolisthesis l5-s1; back and leg pain; degenerative disease l5-s1.The patient underwent removal of hardware, lumbar spine, l5-s1; exploration of fusion, lumbar spine, l5-s1; bone marrow aspiration from the right iliac crest; posterolateral fusion from the transverse process of l5 to the transverse process of s1; placement of pedicle screws at the l5-s1.Two years six months post-op the patient was diagnosed with spondylolisthesis, lumbar spine, l5-s1; degenerative disc disease, lumba r spine, l5-s1; broken hardware, s1 pedicle; severe arthrosis, lumbar spine; chronic back pain, radiculopathy.The patient underwent removal of posterior instrumentation; exploration of fusion; autograft for spine surgery only, morselized through a separate skin incision; allograft for spine surgery only; posterior nonsegmental instrumentation, l5-s1; posterolateral technique, compress of process of l5 to transverse process of s1.As per op notes, scar tissue was removed off the screws.The end caps were then removed.The s1 pedicle screw was then removed.Attempt was made to remove the l5 pedicle screw; but screw was found to be intact.Another incision was made on the right side.The pedicle screws were then dissected.The s1 pedicle screw was found to be broken.It was removed.Fusion mass was then explored.A small incision was made over the right iliac crest.Using quick draw system, several passes were made with harvesting of bone graft from the right iliac crest.After this, bmp was then mixed along with autograft.Using a high speed bur, a hole was made in the sacrum.Pedicle finder was placed on the pedicle and into the body of s1.It was removed, checked with a ball-tipped probe, was found to be intact.Following this, a 7.5 x 35 mm screws was fixed into the s1 pedicle.Same technique was performed on right side.Rods were then placed and secured.Using a high speed bur, the bony elements were decorticated form the transverse process of l5, to the transvers process of s1.After this, iliac crest bone graft was placed into the transverse process of l4, the transverse process of l5, the transverse process of s1, both right and left side.Final placement with bone graft.Screws found to be in good position.No patient complications were reported.On (b)(6)-2009 the patient presented for follow up visit.Impression: status post posterior spinal fusion at l5-s1 for grade ii spondylolisthesis.On (b)(6)-2009 the patient presented for follow up visit.Impression: status post replacement of a broken s1 pedicle screw with augmentation of the bone graft.On (b)(6)-2009 the patient presented for follow up visit.Impression: status post revision at l5-s1 for grade ii spondylolisthesis.The patient underwent five views of lumbar spine.Impression: stable grade ii anterolisthesis involving l5 on s1, with l5-s1 transpedicular hardware in place.On (b)(6)-2010 the patient presented for follow up visit.Impression: status post lumbar fusion at l5-s1 approximately seven months ago.She is still using smokeless tobacco.She is well aware of risks of using tobacco products preventing healing of the fusion process; she still has left shoulder rotator tendinopahty; osteoarthritis of the land.The patient underwent two views of lumbar spine and left shoulder.Impression: stable examination.On (b)(6)-2010 the patient presented for follow up visit.Patient has cold and not feeling well.On (b)(6)-2010 the patient presented for follow up visit.Impression: status post revision of the lumbar fusion at l5-s1 secondary to screw breakage and spondylolisthesis.She still uses smokeless tobacco and is aware that tobacco products can lead to failure of the fusion along with hardware failure, which she sustained before in the past.The patient underwent lumbar spine-two views.Findings: there is transpedicular hardware identified at the l5-s1 level.There is stable grade i anterolisthesis identified involving l5 on s1, with laminectomy defect noted.On (b)(6)-2010, the patient presented for follow up visit.Notes: insomnia, gerd, htn, left hand, djd, anxiety, depression.On (b)(6)-2010, the patient presented for office visit complaining of having long peorids(drw).On (b)(6)-2010, the patient presented for follow up visit complaining of chronic radiculopathy into her right leg.Impression: she is status post lumbar fusion at l5-s1 secondary to grade ii spondylolisthesis.The patient underwent lumbar spine-two views.Findings: prominent spondylolisthesis at l5-s1; heterotropic bone is noted around the margins of this fixation.The patient underwent electromyogram nerve conduction study.Impression: normal motor nerve conduction velocities and latencies in the right tibial peroneal nerves; normal sensory conduction in the right superficial peroneal nerve; normal electromyogram examination of selected muscles of the right lower extremity at rest.Effort could not adequately be evaluated, as the patient was hesitant to exert effort secondary to her discomfort.On (b)(6)-2010 the patient presented for follow up visit.On (b)(6)-2010 the patient presented for follow up visit complaining of right leg pain.Impression: she is status post revision of the lumbar fusion secondary to hardware breakage from the use of smokeless tobacco.On (b)(6)-2010, the patient presented for follow up visit complaining of 3:47 cold, severe pain down legs.On (b)(6)-2010, the patient presented with preop diagnosis of spinal listhesis lumbar spine at l4-l5 and l5-s1; neural foraminal stenosis l5-s1; radiculopathy.The patient underwent fluoroscopic guidance needle placement l4-l5; lumbar interlaminar epidural steroid injection l4-l5.On (b)(6)-2010, the patient presented for follow up visit.Patient has cough tbc.On (b)(6)-2010, the patient presented for follow up visit complaining of bilateral hip pain.Impression: patient is status post lumbar fusion x 2 for grade ii-iii spondylolisthesis of the lumbar spine area.The fusion has healed, but she is having radiculopathy in her legs.It is not intractable.On (b)(6)-2011 the patient presented for follow up visit.Illness: boil on bottom lip.On (b)(6)-2011 the patient presented for follow up visit complaining of buttock pain with tenderness to palpation over the right and left sacroiliac joint and some pain into her legs.Patient has history of spondylolisthesis grade ii.Impression: sacroiliac joint arthropathy, bilaterally, the right is worse than left; grade ii spondylolisthesis status post fusion, stable.On (b)(6)-2011, the patient presented for follow up visit complaining of sacroiliac joint pain.Impression: sacroiliac joint arthropathy and status post lumbar fusion at l5-s1 for grade ii spondylolisthesis.Upon further conversation, the sacroiliac joint injection did help, but only provided approximately one or two days of relief before the pain returned.On (b)(6)-2011, the patient presented with pain on right side of neck, bp medication.On (b)(6)-2011, the patient presented for follow up visit complaining of low back pain, along with radiculopathy into her legs.Impression: patient is status post lumbar fusion at l5-s1 from grade ii spondylolisthesis.On (b)(6)-2011, the patient presented for follow up visit.On (b)(6)-2011, the patient presented with preop diagnosis of disk disease of the lumbar spine, l4-5; grade ii spondylolisthesis of lumbar spine l5-s1; radiculopathy; chronic back pain.The patient underwent fluoroscopic guidance for needle placement, l4-l5; lumbar interlaminal epidural steroid injection, l4-l5.As per op notes the patient back was prepped and draped after taking into op room; 80 mg of kenalog were injected into the interlaminar space.No patient complications were reported.On (b)(6)-2012, the patient underwent electrodiagnostic lower extremity test.Impression: active chronic bilateral l5 radiculopathy.On (b)(6)-2012 the patient presented for follow up visit.On (b)(6)-2013 the patient presented for follow up visit.The patient reported with a rash under her breast and upper inner thigh area.On (b)(6)-2013 the patient presented for follow up visit.On (b)(6)-2013 the patient presented for follow up visit.The patient underwent 3 views of left shoulder, left hip 2 views.Impression: negative.On (b)(6)-2013, the patient presented with cold for follow up visit.
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Event Description
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It was reported that on on (b)(6) 2005 the patient underwent mri of the lumbar spine without contrast.Impression: grade ii isthmic variety spondylochisis at l5-s1 with high grade biforaminal stenosis as the dominant finding.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on (b)(6) 2013, the patient presented with follow-up visit due to back and left hip pain.Assessment: status post lumbar fusion l5-s1 with sacral joint arthropathy both right and left side; trochanter bursitis left hip.
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