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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
Appropriate Term/Code Not Available (3191)
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| Patient Problems
Abdominal Pain (1685); Chest Pain (1776); Diarrhea (1811); Dysphagia/ Odynophagia (1815); Fatigue (1849); Headache (1880); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Hot Flashes/Flushes (2153); Tingling (2171); Stenosis (2263); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Numbness (2415); Neck Pain (2433); Palpitations (2467); Weight Changes (2607)
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Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2008, the patient underwent fusion surgery on the cervical region of her spine at levels c1-c2.The patient was implanted with rhbmp-2/acs, which was applied to the cervical region outside a cage (in the posterolateral gutters and facet joints) post-op, the patient had been marked by progressive neck pain and radiculopathy into her upper extremities.The patient continues to experience severe neck pain with radiculopathy into her upper extremities, headaches, and difficulty turning her head.The patient had difficulty performing her daily life activities.The patient allegedly suffered serious and permanent injuries.
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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.
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Manufacturer Narrative
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Additional information: pt info, device info, (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 (b)(6) 2008, patient underwent following procedure: exploration of c1-c2 fusion.Removal of segmental hardware, c1-c2.C1-c2 arthrodesis with structural autograft.C1-c2 segmental instrumentation with sublaminar hooks and single crosslink.Harvest of right hip autograft (structural).Placement of halo ring and vest.Intraoperative neurophysiologic monitoring with baseline motor evoked potential and emg.Central motor evoked potential bilateral upper and lower extremity intraoperative monitoring; for pre-op diagnosis of: c1-c2 painful implanted fusion hardware.Cervalgia; and post-op diagnosis of: c1-c2 painful implanted fusion hardware.Cervalgia.C1-c2 pseudoarthrosis with vertebral instability.Findings: c1-c2 pseudoarthrosis with vertebral instability confirmed by intraoperative flexion, extension films.Indications: patient underwent skiing accident which resulted in a type 2 odontoid fracture.This was undiagnosed for quite some period of time until she presented with intractable cervalgia and headaches and was diagnosed with vertebral instability.The patient underwent a c1-c2 pedicle screw fixation and fusion with modified brooks sublaminar cables and autograft since that time, the patient has had significant cervalgia, she has also had symptoms consistent with occipital neuralgia.These have improved significantly with injection of the screws with marcaine.She also has a ct of the cervical spine with myelographic contrast that is very suggestive on close inspection of the c 1-c2 interface of the presence of a pseudoarthrosis.The patient presents today for exploration of previous c 1-c2 fusion, removal of hardware and possible revision with placement of a halo vest.As perop notes: ".We then arthrodesed the posterior aspects of c1 and c2 aggressively with the am8 bit and overlaid this with a small bmp sponge and covered this with our harvested autograft mixed with bone graft.No complications were reported." on (b)(6) 2008, patient underwent ct angiogram neck with and without contrast.Impression: revision of posterior c1-2 cervical fusion, patient dominant right vertebral artery with smaller but patent left vertebral body.Patient underwent x-ray of cervical spine.Impression: the patient is intubated.There are retractors posterior to the upper cervical spine the probable marker over the posterior area of c1.On (b)(6) 2008, patient underwent cerebral angiogram and vertebral artery angiogram.Impression: cartoid bifurcation normal, anterior intracranial circulation normal, chronically occluded left vertebral artery at the c2-3 level.This could be due to old dissection, but there is no antegrade flow distal to this level except through vasovasorum, the right vertebral artery is large caliber with antegrade flow.There is reflux into the left vertebral artery as far as the left pica.On (b)(6) 2008, patient underwent ct of cervical spine without contrast.Impression: status post c1-2 posterior element fusion revision with new internal fixation hardware as compared with (b)(6) 2007.The alignment is normal posteriorly in these levels, os odontoideum with deformity of the c1-2 junction anteriorly, unchanged in the interval, mild cervical lordosis, no definite disc protrusion now identified at c5-6 as was seen on the myelographic ct on (b)(6)2007.Some element of the disc protrusion may be missed on this non myelographic ct scan.On (b)(6) 2009, patent presented for office visit due to neck pain and headaches.On (b)(6) 2009, patient underwent procedure for spinal cord stimulator trial due to chronic low back pain with radiculopathy into her bilateral legs.No complications were reported.On (b)(6) 2009, (b)(6) 2010, (b)(6) 2011, patient presented for office visit due to bilateral lumbar spine pain and bilateral neck pain.Physical exam: constitutional: no acute distress.Nourishment type is overweight.Well developed.Musculoskeletal: negative for except as noted in hpi and chief complaint.Cardiovascular: negative for chest pain, cyanosis and irregular heartbeat / palpitations.On (b)(6) 2009, patient underwent pelvic ultrasound due to bladder and back pain.Conclusion: unremarkable except for post-op change of hysterectomy and bilateral oophorectomy.Patient underwent ultrasound of abdomen.Conclusion: negative abdomen ultrasound apart from non-visualization of the pancreatic tail.On (b)(6) 2009, patient underwent procedure for placement of spinal cord stimulator due to history of chronic bilateral lower back pain with radiculopathy into bilateral legs.Patient underwent x-ray of thoracic spine.Impression dual lead stimulator has been placed to the upper t8 level assuming 12 thoracic vertebrae.No change.On (b)(6) 2010, patient presented for office visit due to complaint of cervical radiculopathy.Patient reported severe neck pain.On (b)(6) 2011, patient presented for office visit due to opioid addiction.On (b)(6) 2011, patient underwent procedure for spinal cord stimulator battery replacement.Patient underwent x-ray of abdomen one view with fluoroscopy.On (b)(6) 2012, patient presented for office visit.Patient reported that she develops progressive numbness and tingling predominantly in the thumb, index and second fingers of her hands bilaterally.Patient also reported localized axial neck pain at the cervico-thoracic junction.On (b)(6) 2014, patient presented for office visit due to low back pain.On (b)(6) 2014, patient presented for office visit.On (b)(6) 2015, patient presented for follow-up regarding chronic pain.Patient reported increasing low back pain.Musculoskeletal: normal gait and station, sits comfortably.Neurological: normal coordination upper extremities, normal coordination lower extremities, alert and oriented x3, normal mood and affect.On (b)(6) 2015, patient underwent ct cervical spine without contrast due to chronic neck pain.Conclusion: diffuse cervical spondylosis with straightening of the cervical lordotic curvature and old odontoid fracture with nonunion.Instrumented posterior spinal fusion at c1-2.With specific findings according to level including: solid posterior spinal fusion at c2-3 and c1-2 and posterior pseudoarthrosis at c3-4 with mild left-sided foraminal stenosis at c3-4.2.C6-7, 3 mm central disc protrusion with ventral cord flattening and central spinal canal stenosis measuring 7 mm.Two (2) mm disc protrusions at both the c4-5 and c5-6 levels with mild ventral cord flattening and mild central spinal canal stenosis.Foraminal stenosis on the left which is moderate to severe at c5-6 and moderate at c6-7.No significant interval change.On (b)(6) 2015, patient presented for office visit to discuss results of ct scan.Constitutional: normal body habitus, well groomed, in no acute distress.Musculoskeletal: normal gait and station, sits comfortably.Neurological: normal coordination upper extremities, normal coordination lower extremities, alert and oriented x3, normal mood and affect.On (b)(6) 2015, patient underwent following procedure: cervical epidural with a thoracath under fluoroscopic guidance; for pre-op diagnosis: cervical spondylosis, cervical radiculitis, cervical spinal stenosis.Patient tolerated the procedure well and no complications were reported.
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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) 2008: the patient was diagnosed with chest pain.(b)(6) 2009, patient presented for office visit due to neck pain and headaches and underwent aquatic therapy.On (b)(6) 2009: the patient presented for an office visit with chief complaint of neck and bilateral arm pain, low back and bilateral leg pain.The patient underwent review of systems and physical examination.Impression: neck pain with bilateral upper extremity radiculopathy.Degenerative disc disease of the cervical spine.History of odontoid, c1 and c2 fractures.History of cervical spinal fusion, c1 to c2.Low back pain with bilateral lower extremity radiculopathy.Degenerative disc disease of the lumbar spine.On (b)(6) 2009: the patient was diagnosed for chronic neck and back pain.On (b)(6) 2010: the patient was diagnosed with loose stools and anxiety/depression.On (b)(6) 2010: the patient underwent colon, polyp.On (b)(6) 2010: the patient underwent ct of abdomen and pelvis.Impression: mild fatty infiltration of the liver.Diverticulosis.Cholecystectomy and hysterectomy.No acute findings.On (b)(6) 2010: through a message, the patient complaints of rectal bleeding, black stools, fatigue.Abdominal pain in center of stomach.Colon in (b)(6) 2010, polyps.On (b)(6) 2010: through a telephonic call, the patient complains of diarrhea.On (b)(6) 2010: through a message, the patient informed that the abdominal side has been hurting.On (b)(6) 2011: patient presented with concern of palpitations, hot flashes, night sweats and sinus congestions.Diagnosis: hot flashes, night sweats, post hysterectomy and possibly related to post withdrawal.Palpitations and elevated heart rate possible due to the deconditioning or medication.Sinus congestion, history of recurrent sinus infections.On (b)(6) 2011, (b)(6) 2013: patient presented for an office visit.On (b)(6) 2012: the patient underwent upper abdominal ultrasound due to abdominal discomfort and diarrhea.Impression: no gallbladder abnormality or acute upper abdominal finding.On (b)(6) 2012: the patient underwent "nm" examination of liver and gallbladder due to abdominal pain.Impression: normal accumulation of tracer within the gallbladder and biliary to bowel transit time.Abnormally low gallbladder ejection fraction 2%.On (b)(6) 2012: the patient presented for an office visit for non-nacrotic pain medication.On (b)(6) 2012: the patient presented for an office visit with chief complaint of "uti".On (b)(6) 2012: the patient underwent mri of cervical spine.Findings: mild central stenosis with cord flattening by chronic disc bulge at c5-6 and central caudally extruded disc protrusion at c6-7.Also, the disc bulge or small protrusion with cord abutment, no cord compression and mild left foraminal stenosis.Chronic left-sided mild to moderate c5-6 and c6-7 foraminal stenosis and lesser mild left c4-5 foraminal stenosis.Small left vertebral artery with apparent slow flow.On (b)(6) 2014: patient presented with doing well with initial stages of treatment.Assessment: "lilium is pi/rest.Sacrum is rr/lrr.L4-5 is rr/lrr.L1 is flex/rest in ext.Gluteus and piriformis mm's are tight on r/l.Psoas mm's are tight on r/l.L paraspinals and ql's are tight on r/l.T paraspinals, rhomb and traps are tight on r/l." on (b)(6) 2014: patient presented with left hip ache and pain in left shoulder.Assessment: "l ilium is pi/rest.Sacrum is rr/lrr.L4-5 is rr/lrr.L1 is flex/rest in ext.Gluteus and piriformis mm's are tight on r/l.Psoas mm's are tight on r/l.L paraspinals and ql's are tight on r/l.On (b)(6) 2014: patient returned with complaint of tightening of mid-thoracic to lumbar region and soreness increased.Assessment: " li lium is pi/rest.Sacrum is rr/lrr.L4-5 is rr/lrr.L1 is flex/rest in ext.Gluteus and piriformis mm's are tight on r/l.Psoas mm's are tight on r/l.L paraspinals and ql's are tight on r/l.T paraspinals, rhomb and traps are tight on r/l." on (b)(6) 2013: the patient presented for an office for follow-up for stomach pain and diarrhea and lab work.On (b)(6) 2013: the patient presented with dyspepsia, abdominal pain, diarrhea, intermittent dysphagia and underwent endoscopy with biopsy, dilation.Impression: fine esophageal webs versus tertiary esophageal contradictions, along with eccentric gastroesophageal junction, biopsied and dilated.Significant erosive antritis and gastritis, status post antral biopsy for helicobacter pylori.Mild duodenitis.Empiric small bowel biopsy to exclude malabsorption.Small to moderate internal hemorrhoids.6.Moderate left-sided diverticulosis.On (b)(6) 2013: the patient presented for an office visit for medication check for effexor, possible sinus infection, discussion on resumed smoking habits.On (b)(6) 2013: the patient presented for an office visit with sleeping concerns and complaint of sinus infection.On (b)(6) 2013: the patient presented for an office visit with chief complaint of sinus infection.On (b)(6) 2014: the patient presented for an office visit.On (b)(6) 2014: the patient presented for an office visit for medication check concerning bladder issue.On (b)(6) 2014: the patient presented for an office visit with complaints of sinus infection, stuffy nose, headache, facial pressure since a month.On (b)(6) 2014: the patient presented for an office visit with chief complaint of back pain.On (b)(6) 2014: the patient presented for an office visit with complaint of hip and back pain.The patient underwent x-ray of hip.Impression: normal exam on (b)(6) 2014: the patient presented for an office visit due to pain in hips and underwent rheumatology therapy.On (b)(6) 2014: the patient presented for an office visit with complaint of vaginal pain pressure.On (b)(6) 2014: the patient presented for an office visit with some bladder issues and underwent physical examinations.On (b)(6) 2014: the patient presented for an office visit with compliant of hot flashes.On (b)(6) 2014: the patient presented for an office visit for follow-up and underwent rheumatology therapy.On (b)(6) 2014: the patient presented with average risk for colon and rectal neoplasia and underwent the following procedures: screening colonoscopy.Colonoscopic biopsy polypectomy.On (b)(6) 2014: the patient presented with intermittent diarrhea, history of polyps and underwent colonoscopy with empiric biopsies.On (b)(6) 2015: patient reported with primary complaint of left 1st-3rd finger numbness and pain and left anterior antebrachial pain and tightness.Patient also had secondary complaint of lumbar spine pain and tightness which is a chronic complaint.Assessment: "left wrist flexors and extensors were tight; ilium is pi/rst as, sacrum is rr/lrr, l1 is flex/rest in ext; l paraspinals and ql's are tight on r/l.Gluteus and piriformis mm's are tight on r/l." on (b)(6) 2015: patient returned with persistent symptoms following one treatment that provided moderate relief.Assessment: "left wrist flexors and extensors were tight; ilium is pi/rst as, sacrum is rr/lrr, l1 is flex/rest in ext; l paraspinals and ql's are tight on r/l.Gluteus and piriformis mm's are tight on r/l." on (b)(6) 2015: the patient presented for an office visit and underwent physical examinations along with review of systems.On (b)(6) 2015: the patient presented for an office visit due to sinus.On (b)(6) 2015: the patient presented for an office visit for re-check up of hip and underwent rheumatology therapy.On (b)(6) 2015: the patient presented for left hip pain and requesting a new mri.On (b)(6) 2015: the patient presented for medication refilling and follow up evaluation regarding lower back and hip pain as well as to go over recent ct scans.On (b)(6) 2015: the patient presented for an office visit with complaint of low back pain and neck pain.The patient underwent physical examinations.The x-ray of the patient indicated mild stool, no dilated bowel or freeair, stimulator device was seen.On (b)(6) 2015: the patient was preoperatively diagnosed with lumbosacral spondylosis without myelopathy and underwent bilateral lumbar medial branch block at the l3-l4, l4-l5 and l5-s1 facet levels.On (b)(6) 2015: the patient presented for medications refilling and chronic lower back, hip and neck pain.On (b)(6) 2015: the patient was preoperatively diagnosed with lumbosacral spondylosis without myelopathy and underwent lumbar radiofrequency at bilateral bipolar l3-l4, l4-l5 and l5-s1 facet joint levels.On (b)(6) 2015, (b)(6) 2016: the patient presented for follow up visit for chronic neck pain and low back pain.
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Event Description
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It was reported that on, (b)(6) 2008, patient underwent following procedure: exploration of c1-c2 fusion.Removal of segmental hardware, c1-c2.C1-c2 arthrodesis with structural autograft.C1-c2 segmental instrumentation with sublaminar hooks and single crosslink.Harvest of right hip autograft (structural).Placement of halo ring and vest.Intraoperative neurophysiologic monitoring with baseline motor evoked potential and emg.Central motor evoked potential bilateral upper and lower extremity intraoperative monitoring; for pre-op diagnosis of: c1-c2 painful implanted fusion hardware.Cervalgia; and post-op diagnosis of: c1-c2 painful implanted fusion hardware.Cervalgia.C1-c2 pseudoarthrosis with vertebral instability.On (b)(6) 2008: the patient was discharged.On (b)(6) 2009: the patient presented for an office visit.
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Event Description
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It was reported that on, on (b)(6) 2014, assessment: lower back pain, neck pain, chronic pain.On (b)(6) 2014, patient presented for office visit.Assessment: lumbosacral spondylosis without myelopathy.On (b)(6) 2015, patient presented for office visit to discuss results of ct scan.Patient reports continued pain in her left and right 2nd and 3rd digits of her hands bilaterally, however reports that her left hand is worse in severity than right.Assessment: cervical radiculitis, post laminectomy syndrome, cervical region, cervical spondylosis without myelopathy, neck pain, low back pain, chronic pain.On (b)(6) 2015: the patient presented for left hip pain and requesting a new mri.Assessments: cervical radiculitis, opioid type dependence, chronic pain, cervical spondylosis without myelopathy, postlaminectomy syndrome, cervical region, neck pain, low back pain.On (b)(6) 2015: her lumbar ct from (b)(6) reports mild degenerative central spinal stenosis at the l3-4 and l4-5 with disc bulging and mild facet degeneration, facet arthropathy at the l5-s1 level with the right side worse in severity as compared to the left, a foraminal disc protrusion immediately underling the exiting ganglion and her spinal cord stimulator in place with electrodes entering dorsal epidural space at the t12-l1 level.Her left hip ct reports, mild anterior femoral cam morphology, increased femoral anteversion at + 22 degrees, however no fractures or premature osteoarthritis.Patient reports that her lower back pain is primarily localized in lower left lumbar region.Patient noted that she does experience some left-sided lower extremity pain that does not extend past her knee.Examination: musculoskeletal: lumbar spine: muscular tenderness to palpation-left lower lumbar, tenderness left sij, tenderness trochanteric bursa-left, decreased rom lumbosacral spine, pain with extension/rotation-bending backwards and twisting.Assessments: lower back pain (primary).Lumbar spinal stenosis.Lumbosacral spondylosis without myelopathy.Enthesopathy of hip region.Chronic pain.On (b)(6) 2015: assessment: cervical spondylosis without myelopathy, cervical radiculitis, post laminectomy syndrome, cervical region, neck pain, lumbar spinal stenosis, lumbosacral spondylosis without myelopathy, low back pain, enthesopathy of hip region, chronic pain.On (b)(6) 2015, (b)(6) 2016: assessment: lumbosacral region spondylosis, unspecified hip trochanteric bursitis, spinal stenosis, lumbar region, cervical region radiculopathy, cervical region spondylosis, post laminectomy syndrome, cervicalgia, low back pain.
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Event Description
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It was reported that on (b)(6) 2013, the patient presented for an evaluation and was diagnosed with neck pain and cervicalgia.
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Event Description
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It was reported that on, (b)(6) 2008: patient underwent exercise stress echocardiogram due to chest pain.Conclusion: chest pain atypical for angina at rest and wax and wane with exercise; target heart rate achieved; mildly decreased exercise capacity; normal stress ekg; abnormal diastolic baseline blood pressure (132/90 mm hg); abnormal diastolic blood pressure response to exercise (blood pressure at peak 164/90 mm hg); objectively, negative echocardiogram fro myocardial ischemia at an adequate level of myocardial oxygen demand; normal left ventricular systolic performance; no pericardial effusion.On (b)(6) 2008: patient presented for evaluation of cerebrovascular disease.For which patient underwent carotid artery ultrasound.Conclusions: no significant carotid artery stenosis bilaterally; minimal amount of plaque burden in both carotid systems; patent vertebral arteries and subclavian arteries bilaterally.On (b)(6) 2009: the patient presented for an office visit with several concerns like cold symptoms, runny nose, nasal congestion with green discharge, ear pain and facial pressure.On (b)(6) 2009: the patient presented for an office visit with chief complaint of chronic diarrhea for the past month.On (b)(6) 2010: patient presented with preprocedure diagnosis as: abdominal discomfort, diarrhea, questionable melenic stool, colonoscopy unrevealing for source.For which patient underwent endoscopy with biopsy; colonoscopy with polypectomy and empiric biopsies.Impression: tertiary esophageal contractions; eccentric ge junction, biopsied as above; 4 cm hiatal hernia; mild gastritis and antritis, status post antral biopsy for h.Pylori.; empiric small bowel biopsy to exclude malabsorption; small internal hemorrhoids; small polyp removed as per above; mild to moderate left-sided diverticular disease; empiric biopsies as above.On (b)(6) 2010: the patient was informed of unremarkable colonic biopsies, hyperplastic polyp.On (b)(6) 2010: the patient presented for an office visit with abdominal symptoms, mainly right low abdomen to flank.On (b)(6) 2011: the patient presented for an office visit with chief complaint of continued weight gain.On (b)(6) 2013: the patient called for medication.On (b)(6) 2013: the patient called for fluocinonide refill.On (b)(6) 2012: the patient presented for follow-up.On (b)(6) 2012: the patient called for fluocinonide refill.On (b)(6) 2013: the patient called to report about hurting stomach and black stools.On (b)(6) 2013: patient presented with a follow-up visit due to abdominal pain.On (b)(6) 2014: the patient underwent ct of abdomen and pelvis with contrast.The results were compared to those obtained on (b)(6) 2010.Impression: mild fatty infiltration of the liver.Diverticulosis.Cholecystectomy and hysterectomy.No acute findings.On (b)(6) 2014: patient called to report abdominal pain.On (b)(6) 2014: the patient presented with intermittent diarrhea, history of polyps and underwent colonoscopy with empiric biopsies.Impression: moderate diverticulosis.Moderate internal hemorrhoids.Empiric biopsies.On (b)(6) 2015: patient called for medication refill.On (b)(6) 2015: patient called for medication refill.On (b)(6) 2015: patient called for medication refill.On (b)(6) 2015: patient called for medication refill.
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