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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
Ossification (1428); Chest Pain (1776); Dyspnea (1816); Incontinence (1928); Muscle Spasm(s) (1966); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Urinary Tract Infection (2120); Weakness (2145); Neck Pain (2433)
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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 at l4 to l5 using rhbmp-2/acs.Patient's post-operative period was followed by a temporary period of relief from pain and has subsequently been marked by increasingly severe pain and weakness in his legs.It was reported that the patient underwent a revision surgery on (b)(6) 2005 to remove uncontrolled bone growth and decompress his l4 through l5 nerve roots.Patient continues to experience severe and unrelenting pain that radiates into his 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) 2004 the patient was admitted for severe intractable back and right leg pain.Patient underwent x-ray spine lumbar ap and lat/spot.Impression: unremarkable study of the lumbar spine.On (b)(6) 2004 the patient underwent semi-hemilaminectomy l4-5 right, microdissection, microdiscectomy, removal of multiple axillary free fragments, removal of disc.On (b)(6) 2004 the patient presented for follow-up and reported radicular type pain.On (b)(6) 2004 the patient presented for follow-up.On (b)(6) 2004 the patient underwent lumbar laminectomy.No complications were reported.On (b)(6) 2004 the patient was admitted for lower back, right leg, left shoulder and arm pain.On (b)(6) 2004 patient underwent re-exploration of l4-5 right, transverse posterior lumbar interbody fusion with tlif spacer, 11mm and 6.2x40mm synthes click-x pedicle screws in pedicles of l4-5, microdissection, microdiscectomy.6.2x40mm pedicle screws were placed in the pedicles of l4-5 the bone morphogenic protein along with autologous and crushed cancellous bone into the disc space.An 11 mm synthes tlif spacer was put in and impacted it anteriorly turned transversely.After decorticating the transverse process, additional bone morphogenic protein and crushed cancellous bone was put in laterally.On (b)(6) 2004 the patient underwent anterior cervical discectomy, microdissection, microdiscectomy, removal of ruptured c5-6, anterior cervical fusion with 6mm mtf banked bone dbx and an 18mm synthes clsp locking plate with four 4x14mm self-drilling screws with locking screws.
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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 (b)(6) 2005 the patient called due to terrible pain.On (b)(6) 2007 the patient presented for an office visit and complained of fall.The patient underwent x-rays of foot due to the indication of fifth digit pain.Impression: nondisplaced extra-articular fracture at the shaft of the proximal phalanx fifth digit.On (b)(6) 2009 the patient presented for an office visit and complained of toothache.On (b)(6) 2009 the patient presented for an office visit and complained of injury to lower back.On (b)(6) 2009 the patient underwent ct scan of the head.Impression: right periorbital soft tissue swelling; no acute intracranial abnormality; no intercranial hemorrhage; no mass effect or shift; no fracture; no brain contusion.The patient also underwent ct scan of the cervical spine.Impression: fusion at c5/6 with intervening bone graft material and anterior screw/plate fixation; no fracture; normal alignment, no spondylolisthesis; cervical vertebral disc and body heights preserved.In addition, the patient underwent ct head without contrast due to the clinical indication of head injury.Summary: normal brain for age.Negative for intracranial trauma.Further, the patient also underwent ct spine cervical without contrast for indications of altercation, trauma.Impression: 1.No evidence for acute bony injury.2.Anterior fusion at c5-6 demonstrated.3.Broad-based disc bulge at c3-4, focal posterior herniation not excluded.On (b)(6) 2009 the patient underwent x rays of the lumbar spine due to indication of back injury.Impression: 1.Negative for acute bony trauma 2.Degenerative disc changes at l3-4, l4-5 with associated right paraspinous muscular dystrophic calcification.On (b)(6) 2009 the patient presented for an office visit and complained of abdominal pain.On (b)(6) 2009 the patient underwent ct scan of the abdomen and pelvis due to abdominal pain and vomiting.Impression: 1.Negative for acute abdominal process, negative for stone, renal obstruction or appendicitis.2.Few scattered diverticula with no evidence of diverticulitis.On (b)(6) 2009 the patient presented for an office visit and complained of assault.On (b)(6) 2009, the patient underwent ct head without contrast due to diagnosis of assault.Impression: no acute intracranial abnormality.The patient also underwent x-rays of the nasal bones for the clinical indication of status post trauma.Impression: no acute fracture identified.In addition, the patient also had to undergo x-rays of the cervical spine.Impression: no acute bony injury.The x-rays of the lumbar spine were also taken due to clinical indication of trauma.Impression: no acute fracture or subluxation identified.On (b)(6) 2010, the patient underwent x-rays of the chest due to cough.Impression: chronic change in the left lung base.No obvious acute process.On (b)(6) 2010, the patient presented for an office visit and complained of cervicalgia.On (b)(6) 2010, the patient underwent ct scan of the chest due to chest pain.Impression: 1.On a technical level, the study is adequate.There is no evidence of pulmonary embolism or dissection.2.The patient appears to have had a congenital extralobar sequestration with resection in the left lung.Few surgical clips are seen in this location with a "rounded" atelectasis or scarring and adjacent pleural thickening with calcification.3.Incidental findings: minimal discoid atelectasis right middle lobe; minimal dependent atelectasis; no suspicious consolidation.On (b)(6) 2010 the patient underwent x-rays of the lumbar spine due to back injury.Impression: little change radiographically.There is degenerative spondylosis and osseous arthritic changes from l3 through s1 worse involving the posterior elements particularly to the right.On (b)(6) 2010, the patient presented for an office visit and complained of laceration to forehead.On (b)(6) 2010, the patient underwent x-rays of the chest due to chest pain.Impression: minimal linear pulmonary densities consistent with scarring and possibly atelectasis.On (b)(6) 2010, the patient underwent x-rays of the chest.Impression: minor left basilar atelectasis versus scarring-stable.No acute interval change.On (b)(6) 2010, the patient presented for an office visit and complained of cramp in leg.On (b)(6) 2011 and the following set of dates ((b)(6) 2010), the patient presented for an office visit and complained of lumbago, lumbosacral neuritis.On (b)(6) 2011, the patient presented for an office visit and complained of leg pain.On (b)(6) 2011 the patient underwent x-rays of the knee due to knee pain.Impression: 1.No specific, acute appearing bony abnormalities are seen in the right knee region.2.On the lateral view there is appearance of small focal site of lucency projecting at the posterior aspect of patella.On (b)(6) 2011 the patient presented for an office visit and complained of chest pain.The patient underwent x rays of the chest due to chest pain.Impression: 1.Low lung volumes 2.Chronic bilateral discoid atelectasis vs postinflammatory change without adverse development.On (b)(6) 2011 the patient presented for an office visit and complained of shortness of breath.The patient underwent x-rays of the chest due to difficulty in breathing.Impression: low lung volumes with chronic bibasilar opacities suggesting subsegmental atelectasis or post inflammatory change.There is no acute process.The patient also underwent chest "cta" with pulmonary embolism protocol due to chest pressure and shortness of breath.Impression: 1.No evidence of pulmonary emboli.2.Normal thoracic aorta 3.Postsurgical changes at the medial left lung base as well as chronic rounded atelectasis in the right middle lobe remains stable.There is no evidence of acute cardiopulmonary process.4.Fatty liver.On (b)(6) 2011, (b)(6) 2010 the patient presented for an office visit and complained of multiple problems.The patient underwent ct scan of the head without contrast due to headache.Impressions: no significant intracranial abnormalities are identified.Specifically, no evidence of acute intracranial hemorrhage.2.Evidence of sphenoid-ethmoid sinusitis.There are also findings of sinusitis involving the paranasal sinuses on (b)(6) 2010 exam, indicating a chronic component.The patient also underwent contrast enhanced ct scan of the face due to indication of two days of bilateral facial swelling with congestion and headache.Impression: no evidence of abscess formation.Mild hyperemia of the submandibular glands noted.No sialolith.2.Interval development of air-fluid levels within the maxillary sinuses and subtotal opacification of the ethmoids.On (b)(6) 2011, the patient presented for an office visit and complained of back pain and neck pain.On (b)(6) 2011 and even on (b)(6) 2010 the patient presented for an office visit and complained of neck pain.On (b)(6) 2012 the patient presented for an office visit and complained of joint pain.Diagnosis: spasm of muscle, anxiety and urinary tract infection.The patient underwent x rays of the chest due to cough.Impression: post-surgical changes with bilateral band like scarring.Negative for acute opacity.On (b)(6) 2012 the patient presented for an office visit and got his blood pressure checked.On (b)(6) 2012 the patient presented for an office visit and complained of leg pain.The patient also presented with suicidal ideation and depression.Impression: 1.Major depression, moderate to severe complicated with substance abuse.2.Chronic back pain.On (b)(6) 2012, (b)(6) 2010 the patient presented for an office visit and complained of foot problem and sunburn.On (b)(6) 2012 and the following set of dates( (b)(6) 2011, (b)(6) 2010, (b)(6) 2009, (b)(6) 2008, (b)(6) 2007, (b)(6) 2006, (b)(6) 2014, (b)(6) 2012), the patient presented for an office visit and complained of back pain.The primary diagnosis made were lumbosacral pain and painful lumbar radiculitis.On (b)(6) 2013 and the following set of dates ((b)(6) 2011, (b)(6) 2010) the patient presented for an office visit and complained of chest pain.The patient presented with abdominal pain in the epigastric areas.The symptoms radiated to the back and were described as sharp.On (b)(6) 2014 the patient presented for an office visit and complained of back pain.The pain was acute and chronic and the patient also had decreased range of motion.The pain was located in low back and radiated to both the right and left leg.The patient underwent x rays of the lumbosacral spine due to pain of lumbar fusion.Impression: stable post surgical appearance.There is no acute bony abnormality, no significant listhesis.On (b)(6) 2014 the patient presented for an office visit and complained of insect bite.The patient also had abscess of the right low back.The affected areas are confluent, well demarcated, erythematous, raised, swollen.The patient underwent x-rays of the chest due to cough.Impression:1.No radiographic evidence for acute cardiopulmonary process 2.Scarring left lower lobe.On (b)(6) 2015 the patient presented for an office visit and complained of body and penile pain.The patient had secondary complaints of chronic back pain and chronic leg pain.The patient also had painful urination and having difficulty holding urine.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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On (b)(6) 2004 patient presented with lumbar disc radiculopathy.Patient underwent laminectomy.On (b)(6) 2007 the patient presented for an office visit and complained of fall.The patient underwent x-rays of foot due to the indication of fifth digit pain.Impression: nondisplaced extra-articular fracture at the shaft of the proximal phalanx fifth digit.On (b)(6) 2009 the patient presented for an office visit and complained of toothache.On (b)(6) 2009 the patient presented for an office visit and complained of injury to lower back.On (b)(6) 2009 the patient underwent ct scan of the head.Impression: right periorbital soft tissue swelling; no acute intracranial abnormality; no intercranial hemorrhage; no mass effect or shift; no fracture; no brain contusion.The patient also underwent ct scan of the cervical spine.Impression: fusion at c5/6 with intervening bone graft material and anterior screw/plate fixation; no fracture; normal alignment, no spondylolisthesis; cervical vertebral disc and body heights preserved.In addition, the patient underwent ct head without contrast due to the clinical indication of head injury.Summary: normal brain for age.Negative for intracranial trauma.Further, the patient also underwent ct spine cervical without contrast for indications of altercation, trauma.Impression: no evidence for acute bony injury; anterior fusion at c5-6 demonstrated; broad-based disc bulge at c3-4, focal posterior herniation not excluded.On (b)(6) 2009 the patient underwent x rays of the lumbar spine due to indication of back injury.Impression: negative for acute bony trauma; degenerative disc changes at l3-4, l4-5 with associated right paraspinous muscular dystrophic calcification.On (b)(6) 2009 the patient presented for an office visit and complained of abdominal pain.On (b)(6) 2009 the patient underwent ct scan of the abdomen and pelvis due to abdominal pain and vomiting.Impression: negative for acute abdominal process, negative for stone, renal obstruction or appendicitis; few scattered diverticula with no evidence of diverticulitis.On (b)(6) 2009 the patient presented for an office visit and complained of assault.On (b)(6) 2009, the patient underwent ct head without contrast due to diagnosis of assault.Impression: no acute intracranial abnormality.The patient also underwent x-rays of the nasal bones for the clinical indication of status post trauma.Impression: no acute fracture identified.In addition, the patient also had to undergo x-rays of the cervical spine.Impression: no acute bony injury.The x-rays of the lumbar spine were also taken due to clinical indication of trauma.Impression: no acute fracture or subluxation identified.On (b)(6) 2010, the patient underwent x-rays of the chest due to cough.Impression: chronic change in the left lung base.No obvious acute process.On (b)(6) 2010, the patient presented for an office visit and complained of cervicalgia.On (b)(6) 2010, the patient underwent ct scan of the chest due to chest pain.Impression: on a technical level, the study is adequate.There is no evidence of pulmonary embolism or dissection; the patient appears to have had a congenital extralobar sequestration with resection in the left lung.Few surgical clips are seen in this location with a ¿rounded¿ atelectasis or scarring and adjacent pleural thickening with calcification; incidental findings: minimal discoid atelectasis right middle lobe; minimal dependent atelectasis; no suspicious consolidation.On (b)(6) 2010 the patient underwent x-rays of the lumbar spine due to back injury.Impression: little change radiographically.There is degenerative spondylosis and osseous arthritic changes from l3 through s1 worse involving the posterior elements particularly to the right.On (b)(6) 2010, the patient presented for an office visit and complained of laceration to forehead.On (b)(6) 2010, the patient underwent x-rays of the chest due to chest pain.Impression: minimal linear pulmonary densities consistent with scarring and possibly atelectasis.On (b)(6) 2010, the patient underwent x-rays of the chest.Impression: minor left basilar atelectasis versus scarring-stable.No acute interval change.On (b)(6) 2010, the patient presented for an office visit and complained of cramp in leg.On (b)(6) 2011 and the following set of dates (b)(6), the patient presented for an office visit and complained of lumbago, lumbosacral neuritis.On (b)(6) 2011 the patient underwent two-level bilateral cervical transforaminal epidural steroid injections.The patient presented for an office visit and complained of leg pain.On (b)(6) 2011 the patient underwent x-rays of the knee due to knee pain.Impression: no specific, acute appearing bony abnormalities are seen in the right knee region; on the lateral view there is appearance of small focal site of lucency projecting at the posterior aspect of patella.On (b)(6) 2011 the patient presented for an office visit and complained of chest pain.The patient underwent x rays of the chest due to chest pain.Impression: low lung volumes; chronic bilateral discoid atelectasis vs postinflammatory change without adverse development.On (b)(6) 2011 the patient presented for an office visit and complained of shortness of breath.The patient underwent x-rays of the chest due to difficulty in breathing.Impression: low lung volumes with chronic bibasilar opacities suggesting subsegmental atelectasis or post inflammatory change.There is no acute process.The patient also underwent chest ¿cta¿ with pulmonary embolism protocol due to chest pressure and shortness of breath.Impression: no evidence of pulmonary emboli; normal thoracic aorta; postsurgical changes at the medial left lung base as well as chronic rounded atelectasis in the right middle lobe remains stable.There is no evidence of acute cardiopulmonary process; fatty liver.On (b)(6) 2011, (b)(6) 2010 the patient presented for an office visit and complained of multiple problems.The patient underwent ct scan of the head without contrast due to headache.Impressions: no significant intracranial abnormalities are identified.Specifically, no evidence of acute intracranial hemorrhage; evidence of sphenoid-ethmoid sinusitis.There are also findings of sinusitis involving the paranasal sinuses on (b)(6) 2010 exam, indicating a chronic component.The patient also underwent contrast enhanced ct scan of the face due to indication of two days of bilateral facial swelling with congestion and headache.Impression: no evidence of abscess formation.Mild hyperemia of the submandibular glands noted.No sialolith; interval development of air-fluid levels within the maxillary sinuses and subtotal opacification of the ethmoids on (b)(6) 2011, the patient presented for an office visit and complained of back pain and neck pain.On (b)(6) 2011 and even on (b)(6) 2010 the patient presented for an office visit and complained of neck pain.On (b)(6) 2012 the patient presented for an office visit and complained of joint pain.Diagnosis: spasm of muscle, anxiety and urinary tract infection.The patient underwent x rays of the chest due to cough.Impression: post-surgical changes with bilateral band like scarring.Negative for acute opacity.On (b)(6) 2012 the patient presented for an office visit and got his blood pressure checked.On (b)(6) 2012 the patient presented for an office visit and complained of leg pain.The patient also presented with suicidal ideation and depression.Impression: major depression, moderate to severe complicated with substance abuse; chronic back pain.On (b)(6) 2012, (b)(6) 2010 the patient presented for an office visit and complained of foot problem and sunburn on (b)(6) 2012 and the following set of dates( (b)(6) 2011, 2010, 2009, 2008, 2007, 2006, 2014, 2012), the patient presented for an office visit and complained of back pain.The primary diagnosis made were lumbosacral pain and painful lumbar radiculitis.On (b)(6) 2013 and the following set of dates ((b)(6) 2011, 2010).The patient presented for an office visit and complained of chest pain.The patient presented with abdominal pain in the epigastric areas.The symptoms radiated to the back and were described as sharp on (b)(6) 2014 the patient presented for an office visit and complained of back pain.The pain was acute and chronic and the patient also had decreased range of motion.The pain was located in low back and radiated to both the right and left leg.The patient underwent x rays of the lumbosacral spine due to pain of lumbar fusion.Impression: stable post surgical appearance.There is no acute bony abnormality, no significant listhesis.On (b)(6) 2014 the patient presented for an office visit and complained of insect bite.The patient also had abscess of the right low back.The affected areas are confluent, well demarcated, erythematous, raised, swollen.The patient underwent x-rays of the chest due to cough.Impression: no radiographic evidence for acute cardiopulmonary process; scarring left lower lobe.On (b)(6) 2015 the patient presented for an office visit and complained of body and penile pain.The patient had secondary complaints of chronic back pain and chronic leg pain.The patient also had painful urination and having difficulty holding urine.
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