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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
Abdominal Pain (1685); Chest Pain (1776); Diarrhea (1811); Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Vomiting (2144); Weakness (2145); Burning Sensation (2146); Tingling (2171); Stenosis (2263); Depression (2361); Arachnoiditis, Spinal (2390); Numbness (2415); Neck Pain (2433); Sweating (2444); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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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 posterior lumbar interbody fusion surgery from l4 to s1 using rhbmp-2/acs.Sometime postop, the patient reportedly experienced pain in his lower back, radiating to his lower extremities.He has sensations of numbness and tingling in both legs and is unable to stand or walk for long periods.Due to these symptoms movement is difficult and he must use a cane and back brace to ambulate.
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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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It was reported that on: (b)(6) 2000: patient presented for an office visit.X-ray study of patient was normal.On (b)(6) 2000: patient presented for an office visit.Impression: post traumatic cervicothoracic and lumbar myofascial pain.On (b)(6) 2002: patient underwent x-ray study of pelvis.Impression: negative for significant bone or joint abnormality.08/13/2003: patient presented with complaints of upper back, low back, neck, and bilateral lower extremity pain.Impression: lumbar discogenic pain with history of 2 level disk protrusion, significantly progressive post motor vehicle accident in (b)(6) 2002.On (b)(6) 2002: patient underwent mri of lumbar spine for low back pain, lumbar radiculopathy, and right leg pain.Impression: l4-5 and moderate l5-s1 central disc protrusions.On (b)(6) 2003: patient underwent mri of lumbar spine.Impression: mild degenerative disc disease at the l4-5 level; herniated nucleus pulposus at the l5-s1 level, left paracentral aspect.Patient alsop underwent mri of cervical spine.Impression: mild degenerative disc disease and disk bulge at the c5-c6 level; no evidence of herniated nucleus pulposus and spinal stenosis.On (b)(6) 2003, (b)(6) 2004: patient presented for an office visit.Impression: post-traumatic lumbar discogenic and radicular pain.On (b)(6) 2004: patient presented for an office visit.His cervical scan demonstrated a small protrusion at c5-6 without evidence of significant cord compression.On (b)(6) 2004: patient presented with complaints of low back pain and bilateral leg pain.Patient underwent x-rays of ap and lateral views with flexion and extension views of the lumbar spine, the results were unremarkable except for some minimal loss of disk space height at l4-5 and l5-s1.On (b)(6) 2004: patient underwent ct scan of the lumbar spine.Impression: posterior midline annular fissure at l4-5 level; posterior annular tear at the l5-s1 level with left paracentral herniated nucleus pulposus.On (b)(6) 2004: patient presented for an office visit to follow up on his lumbar diskogram procedure.On (b)(6) 2004: patient got admitted and was diagnosed pre-operatively with lumbar disk herniation.Patient underwent the following procedures: lumbar microdiskectomy, l5-s1, left side.On (b)(6) 2004: patient presented for an office visit to follow up.On physical examination he had cervicothorasic spasms and positive slump on the right.Extension of the cervical spine was limited.On (b)(6) 2004: patient presented for follow-up.Impression: lumbar post laminectomy syndrome.On (b)(6) 2004: patient returned for follow up.Impression of the visit: low back pain on (b)(6) 2004: patient returned for follow up.Impression of the visit: lumbar radiculopathy, depression (b)(6) 2005: patient presented with chief complaint of low back pain.Patient underwent mri of the lumbar spine, which showed a mild midline disc-herniation at l4-5, which does not appear to be compressing nerve root.Impression: lumbar radiculopathy (b)(6) 2005: patient got admitted and was diagnosed pre-operatively with lumbar radiculopathy.Patient underwent the following procedures: lumbar laminectomy with decompression, l4, l5 and s1; interbody arthrodesis l4-5 and l5-s1; placement of interbody cage l4-5 and l5-s1; posterolateral arthrodesis 5) placement of pedicle screws and rods from l4 to s1 bilaterally using the instrumentation; lumbar fusion, 360 degree, performed through 2 separate incisions; autograft; bone morphogenic protein; microscopic dissection per op-notes: ¿progressive dilators from the system were placed, down to the lamina of l5 until a 22 x 80 mm fixed dilator was secured¿a gelfoam sponge soaked with bmp was packed into the interspace at l4-5.Autograft was then packed over this.After placement of several trials, a 26 x 10 mm cage was chosen.It was packed with a bmp- soaked sponge.This was then carefully tapped into the interspace at l4-5 under fluoroscopic guidance.At l5-s1 we again packed the interspace with a bmp sponge and autograft.An 8 x 26 mm cage packed with a bmp sponge was then tapped into the interspace at this level.¿ on (b)(6) 2007: patient presented for a follow up for medication refill.On (b)(6) 2005: patient underwent mri of lumbar spine pre and post contrast.Impressions: no evidence of recurrent hnp, stenosis, and significant epidural fibrosis at l4-5 level.Additionally at l5-s1 level, there may be a small epidural abscess ventrally along central and left paracentral aspect.Discitis is also likely.
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Manufacturer Narrative
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Additional information: relevant tests/lab data, other relevant history, (b)(4).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) 2005 patient presented for an office visit due to low back pain.On (b)(6) 2006 patient presented for an office visit due to back pain.Musculoskeletal: cervical spine range of motion: moderately decreased and extension restricted.Lumbosacral range of motion: moderately decreased, flexion restricted, extension restricted and flexion painful.On (b)(6) 2006 patient presented for an office visit due to low back pain.On (b)(6) 2006 patient presented for an office visit due to back pain and neck pain.Review of symptoms: general: night sweats.Cardiovascular: chest pain.Gastrointestinal: abdominal pain, diarrhea and vomiting.Neurological: crying spells and problem sleeping.On (b)(6) 2006 patient presented for an office visit due to low back pain, left leg pain, neck pain and left arm pain.Musculoskeletal: cervical spine: flexion restricted and painful and extension restricted and painful.On (b)(6) 2006 patient presented for an office visit.On (b)(6) 2006 patient underwent x-ray of "l/s" spine ap/lateral; stable since last visit with no loosening of hardware.On (b)(6) 2006 patient underwent stable mri since last study with no recurrent "hnp" or stenosis.On (b)(6) 2007 patient presented for an office visit due to low back pain, and neck pain.On (b)(6) 2007, patient presented for an office visit due to pain and medication refill.On (b)(6) 2007: patient presented for a follow up for medication refill.On (b)(6) 2007 patient underwent x-ray of lumbar spine.Intact fusion hardware l4/5/1, hip joints unremarkable.On (b)(6) 2007, (b)(6) 2008: patient presented for office visit for follow up on back pain and depression.Patient reports pain stiffness, numbness and weakness.Review of symptoms is positive for paresthesia in both lower legs.Assessment: back pain, constipation, major depressive affective disorder, dyslipidemia.On (b)(6) 2007 patient presented for an office visit due to medication refill and pain.On (b)(6) 2008 patient presented for an office visit due to low back pain, upper back pain.Review of symptoms: general: fever, night sweats.Cardiovascular: chest pain.Gastrointestinal: abdominal pain, diarrhea, vomiting.Neurological: crying spells and problem sleeping.On (b)(6) 2008 patient presented for an office visit due to upper back pain.On (b)(6) 2008 patient presented for an office visit due to upper back pain, low back pain, neck pain and headache.On (b)(6) 2008 patient presented for an office visit due to upper back pain, low back pain, right leg pain, left leg pain, neck pain and chronic pain.Thoracic spine - musculoskeletal: range of motion: flexion restricted and pain and extension restriction and painful.Lumbar spine - musculoskeletal: range of motion: flexion restricted and painful and extension restricted and painful.On (b)(6) 2009 patient underwent mri of lumbar spine."s/p l4-5, l5-s1 diskectomy with pedicle screws fusion from l4 to s1, finding of arachnoiditis.On (b)(6) 2009 patient underwent mri of cervical spine.Disc disease with ventral impingement at c5-6, c6-7, neural foraminal narrowing at c5-6, c6-7.On (b)(6) 2009 patient presented for an office visit due to back pain, low back pain, left leg pain, neck pain, left hip pain and chronic pain.On (b)(6) 2009 patient presented for a follow up visit due to upper back pain, low back pain, left leg pain, neck pain, left arm pain, left hip pain and chronic pain.On (b)(6) 2009 patient had right thoracic paraspinal trigger point injection.On (b)(6) 2009: patient presented for office visit for preoperative evaluation.Patient has had a growth on top of his right foot that is increasing in size.Patient complains of dull aching pain with radiation to leg.On (b)(6) 2010: patient presented for office visit for management of following problems: dyslipidemia, hypertension.Assessment: bursitis, hypertension, hyperlipidemia.On (b)(6) 2011: patient presented for office visit.Patient reports postoperative archnoditis.Patient has chronic pain and numbness in the lower back region, worse with movement and turning.Assessment: hypertension, hyperlipidemia, back pain.On (b)(6) 2011: patient presented for office visit for follow-up on back pain with radiculopathy.Patient has painful range of motion and pain in back is more than in legs.Patient doe have some weakness with ambulation on the left and has difficulty with sleeping.Assessment: chronic back pain.
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Event Description
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It was reported that on (b)(6) 2013, (b)(6) 2014: the patient presented for follow up on lab results.On (b)(6) 2014: the patient presented with hip pain, back pain burning in nature, intermittent, sharp, located in the lumbar region, in the midline; aggravated by activity, neck pain which is burning in nature, intermittent, sharp and stabbing.On (b)(6) 2013, (b)(6) 2014, (b)(6) 2015, (b)(6) 2016: the patient presented for medications refilling.On (b)(6) 2015: the patient underwent mri of lumbar spine.Impression: postoperative changes in the lower lumbar spine with pedicle screws bilaterally at l4 and s1 with post laminectomy changes l4-l5 and l5-s1 with post discectomy changes with disc prostheses at l4-l5 and l5-s1.Hypertrophic or osteoarthritic type change arising from the inferior body of l5 off to the left.
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