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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 7510600 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Fever (1858); Headache (1880); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Weakness (2145); Tingling (2171); Dysphasia (2195); Stenosis (2263); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Chest Tightness/Pressure (2463); 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 spinal fusion surgery from l5 to s1, during which rhbmp-2/acs was used.The patient¿s post op period has reportedly been marked by increasing pain and weakness in his legs.The patient also underwent a revision on (b)(6) 2005 to decompress the s1 nerve root due to significant bone growth.The patient continues to experience pain, numbness and burning down 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).
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Event Description
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It was reported that on (b)(6) 2013, the patient presented with prep diagnosis of chronic low back pain, secondary to spinal stenosis and underwent an l3-4 interlaminar lumbar epidural steroid block under fluoroscopic guidance and contrast confirmation.
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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) 2003 the patient underwent x-rays of thoracic spine.Impression: essentially normal exam for age with minor degenerative changes in the lower thoracic segments.(b)(6) 2004: the patient presented for degenerative disc disease with current disc herniation status post recent repeat trauma.(b)(6) 2004 the patient presented with worsening back pain status post anterior lumbar interbody fusion l5-s1.(b)(6) 2005: patient consulted regarding back and leg pain.(b)(6) 2005: patient presented due to weakness, low back pain.(b)(6) 2005: patient was diagnosed with low back pain.Patient presented due to decrease in range of motion, functional mobility.(b)(6) 2005, (b)(6) 2006: the patient presented for a follow up for chronic low back pain and leg pain.(b)(6) 2006: patient was diagnosed with neck pain, arm numbness and evaluate stenosis.(b)(6) 2012: patient consulted for chief complaint of low back pain, leg pain, bottom hips.(b)(6) 2012: pre-operative diagnosis: lumbosacral radiculopathy (b)(6) 2013: patient underwent mri lumbar spine with and without contrast.Impression: moderate degenerative spinal stenosis at l2-l3 level.Normal postop laminectomy findings are seen at l5-s1 level without herniated nucleus pulposus or spinal stenosis.(b)(6) 2013, (b)(6) 2014, (b)(6) 2015: the patient presented for a follow up on chronic low back pain due to ruptured disc.(b)(6) 2013: patient presented for physical therapy with a primary complaint of low back and leg pain.(b)(6) 2013, (b)(6) 2014: patient presented in the facility due to low back pain.(b)(6) 2013, (b)(6) 2014: patient presented for an office visit due to low back pain.(b)(6) 2014, (b)(6) 2014: patient presented for chief complaint of low back pain.He had been having increased neck pain with radiating pain down arms with numbness.Patient review of systems revealed: musculoskeletal: limb pain and joint stiffness; neurological: headache, numbness and tingling.Patient was diagnosed with lumbar pain, neck pain.Physical examination revealed: lumbosacral spine: tenderness: level l5 lumbar spine, left sciatic notch and right sciatic notch.Flexion was restricted.Extension was restricted.Rotation to the left was restricted.Rotation to the right was restricted.(b)(6) 2015: patient presented for chief complaint of low back pain which radiates down bilateral leg with numbness and tingling.He stated that walking and standing increases his pain.Patient had increased numbness and tingling in his arms and legs.His bilateral arm pain begins in his neck and radiates through his shoulders and down into his hands.He had neck pain that has increased significantly with headaches.He cannot feel his fingertips on either hand."his pain was increased daily and cannot do anything without his pain".Patient review of systems revealed: musculoskeletal: arthralgias, limb pain and joint stiffness; neurological: headache, numbness, tingling and bilateral arms and legs.Patient was diagnosed with carpal tunnel syndrome, lumbar pain, neck pain, lumbar stenosis with neurogenic claudication.(b)(6) 2015: patient was diagnosed with low back pain.(b)(6) 2015: patient underwent ct scan of the lumbar spine without contrast followed by coronal and sagittal reconstruction of the images.Impression: no acute bony fractures or dislocations are seen in the lumbar spine.Patient also underwent non contrast enhanced ct scan of the brain.Impression: no acute intracranial hemorrhage, intra-axial mass lesion or mass effect was seen.Patient also underwent ct cervical spine w/o contrast due to trauma.Impression: no acute bony fractures or dislocations in the cervical spine.
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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 (b)(6) 2004: the patient presented with pre-op diagnosis: degenerative disc disease l5-s1.Recurrent disc herniation right side l5-s1.The patient underwent: anterior fusion l5-s1.Anterior discectomy right side l5-s1 under microscope.Use and supervision of microscope for right anterior discectomy.Anterior cage instrumentation using lt cages l5-s1.Use of rh-bmp2/acs solution for bone grafting.Per-op notes: discectomy of l5-s1 interval was performed.The lt cage instrumentation was placed in position.The appropriate sized 18mm lt cages 26mm in length were selected and placed.The cages were filled with rh-bmp2/acs solution on the appropriate sponge vehicle.The patient presented with pre-op diagnosis: incapacitating lumbar disc disease, recurrent, l5-s1.The patient underwent: anterior in traperitoneal and vascular dissection, low anterior discectomy of that level.The patient was discharged on (b)(6) 2004.No patient complications.On (b)(6) 2004: the patient underwent x-ray of lumbar spine.Assessment: radicular right leg pain two weeks spine alif l5-s1 with discectomy.Instrumentation in exact position.On (b)(6) 2004: the patient underwent mylogram lumbar spine.Impression: inter-body fusion implants in the l5-s1 disc space.Normal lumbar mylography.The patient underwent ct lumbar spine with contrast.Impression: absence of any disc herniation or caudal sac stenosis in the lumbar lower spine.On (b)(6) 2004: the patient underwent mri of spine-lumbar w and w/o contrast due to lumbar radiculopathy.Impression: post surgical changes seen at the level of l5-s1 with caging procedure.Postoperative scar at the level of l5-s1 on the right side.Mild paracentral disc herniation at the level of l4-l5.On (b)(6) 2005: the patient underwent x-ray of lumbar spine.Impression: a surgical instrument projected over the posterior interior aspect of the l5 vertebral body.Stable appearance of visualized bones with l5-l6 disc prosthesis grossly stable in position.On (b)(6) 2005: the patient presented with pre-op diagnosis: status post anterior fusion, lt cagerh-bmp2/acs with possible pseudoarthrosis.Mild to moderate stenosis, l5-s1.The patient underwent: posterior bilateral decompressive laminectomy, l5-s1.Exploration and inspection of fusion mass, l5-s1.Post-op diagnosis: mild to moderate stenosis, l5-s1.Solid fusion l5-s1.On (b)(6) 2005: the patient presented for a follow up for low back pain.On (b)(6) 2005: the patient presented for a follow up for chronic low back pain.On (b)(6) 2005: the patient presented with chest cold and head cold.On (b)(6) 2006, and (b)(6) /2005: the patient presented for a follow up for chronic low back pain and leg pain.On (b)(6) 2006: the patient presented for a follow up.On (b)(6) 2006: the patient underwent mri of spine w/o contrast due to neck pain, bilateral arm numbness.Impression: minimal spondylotic changes at c5-c6 and c6-c7 levels without any evidence of focal disk extrusions or segmental spinal stenosis or neuroforaminal stenosis.Small right paracentral disk protrusion at c5-c6 and a small broad based disk osteophyte complex at c6-c7 level minimal effacing anterior cerebrospinal fluid space.From 2007 till 2011, the patient was diagnosed with back pain, headaches, neck pain, and respiratory issues.On (b)(6) 2011: the patient presented with fever.Diagnosis: left lower lobe pneumonia.The patient underwent x-ray of chest.Impression: negative.On (b)(6) 2011: the patient presented with fever.Diagnosis: sepsis, pneumonia, fever, headache, elevated crp, thrombocytopenia, monocytosis.The patient underwent x-ray of chest.Impression: left lower lobe atelectasis.The patient underwent ct of chest.Impression: infiltrates in the left lung as well as the left lung base posteriorly.Small left pleural effusion.Assessment: febrile illness, pneumonia, thrombocytopenia, maculopapular skin rash, bilateral cervical lymphadenopathy.The patient underwent ct of head w/o intravenous contrast.Impression: negative.The patient underwent x-ray of chest due to dyspnea.Impression: suspicious for an area of atelectasis or pneumonia adjacent to the left cardiac margin.The patient underwent x-ray of chest due to fever.Impression: left lower lobe atelectasis versus developing pneumonia.The patient underwent x-ray of chest.Impression: adequate placement a left picc line.Persistent opacification of the left base.The patient underwent ct of chest due to fever, headache, cough and body aches.Impression: infiltrates in the left lung, lingular segment, as well as the left base posteriorly.Small left pleural effusion.On (b)(6) 2012: the patient presented with back pain with radiation and chest tightness.The patient underwent x-ray of chest.Impression: no acute chest disease.Previously seen moderately left lower lobe infiltration has resolved.On (b)(6) 2012: the patient underwent mri lumbar spine w/wo contrast due to back pain.Impression: mild generative spinal stenosis at l2-l3 level due to large circumferential bulging annulus.Moderate circumferential bulging annulus seen at l4-l5 with mild bilateral neural foramina stenosis.Postlaminectomy findings and cage prosthesis placement is seen at l5-s1 level without spinal stenosis.On (b)(6) 2012: the patient underwent right l3-4 transforaminal epidural steroid injection.On (b)(6) 2013: the patient presented with pre-op diagnosis: chronic low back pain and right lower extremity pain secondary to failed back surgery syndrome, spinal stenosis at l2-l3 and l4-l5 with broad based disc bulge at l4-l5 and mild foraminal narrowing at l5.The patient underwent: a right l3 lumbar transforaminal epidural block with pulsed radiofrequency under fluoroscopic guidance.On (b)(6) 2012, and (b)(6) 2013: the patient presented for a follow up on chronic low back pain.From 2013-2014, the patient was diagnosed for nerve block and back pain.On (b)(6) 2014: the patient underwent mri of lumbar spine w/wo contrast due to low back pain.Impression: stable appearance of moderate degenerative spinal stenosis at l2-l3 level with mild bilateral neural foramina stenosis.Mild degenerative spinal stenosis at l3-l4 level.Stable appearance of the laminectomy findings at l5-s1.Prior to rh-bmp2/acs surgery, the patient was suffering from the following problems: degenerative disk disease l5-s2 and recurrent disk herniation right side l5-s1 causing lower back and leg pain.After the rh-bmp2/acs surgery, the patient is suffering from the following injuries: difficulty speaking; nerve injury; osteoarthritis; radiating pain to the legs; significant pain; leg spasms; shooting pain from shoulders and arms resulting in permanent numbness in hands; cyst in back.He also has the following symptoms: constant pain in my lower back and legs; muscle weakness, violent leg spasms, difficulty walking, and memory loss.The patient also has difficulty in walking long distances.
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Event Description
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It was reported that on (b)(6) 2004: patient presented for follow-up after four months status post anterior fusion.Patient continues to have pain, takes an occasional lortab.Patient's ap and lateral view of lumbosacral spine showed the lt cage in good position with no sign of collapse or deformity.On (b)(6) 2005: patient got discharged after being diagnosed with spinal stenosis.On (b)(6) 2013, patient presented for physical therapy with a primary complaint of low back and leg pain.On (b)(6) 2014, patient underwent mri of lumbar spine w and w/o contrast due to low back pain/radiculopathy.Impression: stable appearance of moderate degenerative spinal stenosis at l2-3 level with mild bilateral neural foramina stenosis.Mild degenerative spinal stenosis at l3-4 level similar to the prior exam.Stable appearances of the postop laminectomy findings at l5-s1 level, no new findings are seen.On (b)(6) 2015: patient presented for office visit due to right ear pain.On (b)(6) 2015: the patient underwent ct of thoracic spine without contrast.Impression: no acute body fractures or dislocations seen in thoracic spine.On (b)(6) 2015: patient presented for office visit due to fall.Patient reported chronic lumbar pain, headache, neck, upper back and lower back pain.Pain was radiating into left shoulder.Patient underwent ct of cervical spine due to trauma or fall.Impression: no acute bony fracture or dislocations in the cervical spine.Patient underwent ct of head or brain w/o contrast.Impression: no acute intracranial hemorrhage, intra-axial mass lesion or mass effect is seen.Patient underwent ct of lumbar spine w/o contrast.Impression: no acute bony fractures or dislocations are seen in the lumbar spine.
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