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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stacking Breaths (1593); Syncope (1610); Angina (1710); Arthritis (1723); Bronchitis (1752); Chest Pain (1776); Diarrhea (1811); Dyspnea (1816); Edema (1820); Pulmonary Emphysema (1832); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Pneumonia (2011); Red Eye(s) (2038); Transient Ischemic Attack (2109); Urinary Tract Infection (2120); Weakness (2145); Tingling (2171); Cramp(s) (2193); Dizziness (2194); Chronic Obstructive Pulmonary Disease (COPD) (2237); Depression (2361); Numbness (2415); Fungal Infection (2419); Neck Stiffness (2434); Ambulation Difficulties (2544); Hematuria (2558); Bronchospasm (2598); Osteopenia/ Osteoporosis (2651)
Event Type  Injury  
Event Description
It was reported that the patient underwent an l5-s1 tlif using an interbody cage and rhbmp-2/acs, as well as bilateral posterolateral fusion at the same level.The rhbmp-2/acs was placed within the cage, anteriorly in the disc space prior to insertion of the cage, and bilaterally along the gutters of the transverse process of l5.Sometime postop, the patient reportedly developed pain, suffering, symptoms and disability.The patient has developed progressive, disabling pain and numbness in her lower back, radiating to her legs.Patient continues to have difficulties walking and often falls.
 
Manufacturer Narrative
(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.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Event Description
Per medical records it was reported that on (b)(6) 2011: the patient underwent x-ray of left foot due to trauma.Impression: no acute abnormality.
 
Manufacturer Narrative
Per the image review, the findings are as follows: (b)(6) 2007 chest x-ray pa and lateral views show elongated chest cavity, but normal lung fields, cardiac shadow, bony anatomy and breast shadows.Slight prominence of right hilar markings noted.Lateral view shows flattened thoracic kyphosis.No fractures or advanced degenerative changes.Brain ct c1/2 appears normal.No other spinal anatomy imaged.(b)(6) 2010 lumbar series multiple lumbar views show advanced degenerative changes at l5.Alignment is otherwise normal.Ap view shows right sided l5 hemi-laminotomy consistent with previous discectomy.Oblique views show slight facet arthritis at l5 as well chest x-ray pa and lateral views show elongated chest cavity, but normal lung fields, cardiac shadow, bony anatomy and breast shadows.Slight prominence of right hilar markings noted.Lateral view shows flattened thoracic kyphosis.No fractures or advanced degenerative changes.(b)(6) 2010 lumbar x-rays single inter operative lateral view with localizing freer elevator at the l5 disc.Next lateral view shows pedicle screws now in position at l5 and s1.Final view shows screws with peek spacer in the l5 disc.(b)(6) 2010 lumbar ct axial levels above l5 appear normal.Screws are present at l5 and s1.Spacer is well positioned within the l5 disc.Facetectomy has been performed on the right.Some heterotopic bone exists in this area without nerve compression.(b)(6) 2011 chest x-ray pa view shows elongated chest cavity, but normal lung fields, cardiac shadow, bony anatomy and breast shadows.Slight prominence of right hilar markings noted.No fractures or advanced degenerative changes.
 
Event Description
It was reported that on (b)(6) 2002: the patient underwent for bilateral mammogram due to lt breast mass.Impression: stable operating glandular pattern of both breasts.No abnormalities are identified.On (b)(6) 2005: the patient underwent for ct scan of head with and without contrast due to migraine.Impression: nonspecific ct evaluation of the head with and without intravenous contrast.The patient also underwent for bilateral mammogram screening.Impression: there is a new group of small calcifications seen in the outer half of the right breast located relatively near the nipple shadow.Additional views of the calcifications are recommended for better localization and characterization.On (b)(6) 2005: the patient underwent for right diagnostic unilateral mammogram due to abnormal mammogram right breast.Supplemental compression spot views revealed no evidence of microcalcifications, parenchymal distortion or masses that would indicate biopsy consideration.On (b)(6) 2007: the patient presented with chief complaint of fever and headache.Physical examination revealed some stiffness to the neck.Chest showed coarse rhonchi and harsh cough.Assessment: headache.Acute bronchitis.Patient also underwent for urinalysis and hematology.The patient also underwent for ct scan of head without contrast due to fever.Impression: nonspecific ct evaluation of the head done without intravenous contrast.The patient also underwent x-ray of chest due to fever.Impression: normal chest.On (b)(6) 2010: the patient underwent for mri of lumbar spine without contrast.Impression: moderate disc herniation centrally at l5/s1; degenerative disc disease.On (b)(6) 2010: the patient presented with weakness on the right leg which caused her to fall sometimes.Patient also reported pain on right hip and also had ecchymosis and pain in upper forearm.On (b)(6) 2010: the patient presented with chief complaint of low back pain and has gotten worse over past few months causing right lower extremity pain.Patient's workup also included mri of the lumbar spine.Patient also had physical therapy and epidural injections in the past.Review of the patient's mri revealed degenerative disc disease and the endplate changes at l5-s1.On same day patient also underwent for urinalysis.Patient also underwent for x-ray of chest due to cough, fatigue, soa, pre-op, lumbar ddd, low back pain.Impression: normal chest.On same day, patient also underwent for x-ray of lumbosacral spine complete with bending.Impression: mild degenerative disk disease.On (b)(6) 2010: the patient was admitted with history of intractable back pain and radiculopathy, right greater than left.The patient had the following pre-op diagnoses: l5-s1 degenerative disc disease with instability and radiculopathy.The patient underwent following procedures: right transverse set approach for diskectomy.L5 inferior laminotomy, s1 superior laminotomy, l5-s1 medial facetectomy for decompression of the right l5 and s1 nerve root.Transpedicular screw instrumentation bilateral at l5 and s1.Transforaminal interbody arthrodesis using peek cage and local bone graft for arthrodesis and infuse bmp l5-s1.Bilateral posterolateral arthrodesis using compression resistant matrix, infuse, and local bone graft l5-s1.Per op notes, a 8 mm trial graft was placed and this appeared to have good contact with both the superior and inferior aspect of vertebral body and sacrum.Peek cage of the same size was then packed with infuse and local bone graft, which had been morcellized previously.The infuse; which is a large package was cut into 3 equal pieces.One of these pieces was again cut into thirds and this was placed in the peek cage along with locally harvested bone graft.Another was placed anterior along with the morcellized bone graft into the disk space.The interbody cage was then packed with bone graft and was inserted in transforaminal fashion.The cage was turned in correct position and tagged anteriorly.Remaining of the morcellized bone was then packed posterior to the graft.Compression resistant matrix along with morcellized bone and bmp sponge were placed into the bilateral gutters on transverse process of l5 to the sacral ala bilaterally.The patient also underwent for multiple x-rays of lumbar spine due to lumbar fusion, intra-op, which demonstrated that: there had been localization of the l5-s1 disk level with a radiopaque probe for site verification; surgical hardware was seen in projection with the l5 and s1 vertebra; disk spacer had been placed at the l5-s1 disk level.Previously noted intrapedicular screws at the l5-s1 level were stable and unremarkable.The alignment of the lower lumbar elements and sacrum appeared to be anatomic on this one view.No patient complications were noted.On (b)(6) 2010: the patient was discharged without complications in good condition.Her pain was well controlled.On (b)(6) 2010: the patient presented with complaint of having trouble in sitting up status post l5-s1 fusion.Patient was smoking less than half pack a day.On (b)(6) 2010: the patient presented with complaint of mild right hip pain status post lumbar fusion which had vastly improved from her previous visit.Patient also reported history of a fall and has not any imaging for seeing.There were no significant changes during her review.On (b)(6) 2010: the patient underwent for ct scan of lumbar spine without contrast due to low back pain.Impression: the patient is status post fusion procedure at l5-s1 in anatomic alignment.Compression of the cephalad end-plate of t12.On (b)(6) 2010: the patient presented for follow-up status post lumbar fusion.Patient had a fall and now had right lower extremity radicular pain.Patient's latest ct scan review good bony fusion healing.On (b)(6) 2010: the patient presented for follow-up status post lumbar fusion and complained of lot of low back pain and right hip pain.Patient continued to smoke.A ct scan of patient was obtained which showed a good bony fusion in interbody space and no significant posterolateral fusion.Patient was also counselled for smoking cessation to help her in overall condition.On (b)(6) 2010: the patient presented for follow-up status post lumbar fusion with complaint of severe pain constantly in right hip and stated that it has not improved since last visit.Patient still continued to smoke.On (b)(6) 2011: the patient presented with complaint of chest pain that had gotten worse lately and felt some headache.Patient also reported of some shortness of breath and fatigue.Impression: chronic obstructive pulmonary disease.Possible hypertension.Hyperlipidemia.On (b)(6) 2011: the patient underwent for x-ray of chest due to chest pain.Impression: normal chest.On (b)(6) 2011: the patient presented for a visit due to midsternal chest pain which started last night after an incident at home where she had an argument with someone and stated that she had a significant anxiety attack.On (b)(6) 2011: the patient presented for a visit due to shortness of breath.On (b)(6) 2011: the patient presented with main complaint of having surgery on her back and hip and it failed.On (b)(6) 2011: the patient presented for a visit due to backache.On (b)(6) 2011: the patient presented for a cardiology follow-up visit due to chest pain.Impression: atypical chest pain.
 
Manufacturer Narrative
(b)(4).
 
Event Description
(b)(6) 2002: patient presented for psychiatric evaluation.Per doctor, patient was distressed and paranoid ideation was noted.Insight and judgment appeared markedly impaired (b)(6) 2008 the patient underwent ultrasound study of the carotid artery, bilateral.Impression: no hemodynamic stenosis is seen in the carotid arteries.Elevation of the velocity of the right cca could indicate a stenosis at the level of the aortic arch or more proximal (b)(6) 2008 the patient underwent x-rays of the chest due to airway obstruct.Impression: no acute disease in the chest.(b)(6) 2008 the patient presented with the chief complaint of cough and dyspnea.The patient underwent x-rays of the chest.Impression: no acute disease in the chest.(b)(6) 2008 the patient presented with the chief complaint of chest pain.The pain was described as sharp in character associated with dyspnea.The pain radiated to the left arm, leaving the fingers numb.Ecg showed normal sinus rhythm, no acute changes.She also had periods of bradycardia.The patient underwent x-rays of the chest.Impression: old granulomatous disease.No acute process (b)(6) 2008: patient presented with chest pain and left sided numbness and weakness.Patient had been noticing on and off exertional chest pain, which had been much more severe for the last week.Patient had an episode of syncope.Impression: unstable angina, syncope, copd, recent transient ischemic attack.(b)(6) 2008: patient underwent mri of head without contrast due to history of syncope and collapse.Impression: no acute hemorrhage or infarcation.The visualized ventricles, sulci and cisterna are preserved and consistent with the patient's stated age.Patient underwent ec echo.Patient underwent following procedures: left heart catheterization.Left ventricular angiogram.Selective coronary arteriogram.Abdominal aortogram.Diagnosis: unstable angina.Impression: minimal proximal left anterior descending disease around 20%.Normal left ventricular function.Normal renal arteries.(b)(6) 2008 the patient presented with the chief complaint of chest pain.The pain was described as sharp in character in the left precordium and radiation to the left shoulder associated with nausea.She also experienced tingling sensation of the left hand and short of breath.Assessment: chest pain secondary to coronary artery disease; hypertension; low back pain; copd.The patient underwent x-rays of the chest.Impression: no acute disease in the chest.(b)(6) 2008 the patient was discharged from the hospital.Discharge diagnoses: chest pain, not specified; hypertension; low back pain; copd (b)(6) 2009 the patient presented with the chief complaint of chest pain.She described the pain as pressure like in character and sharp.She also has had pain in the left elbow, associated with numbness of the left shoulder and tingling sensation on the hands and fingers on the right side.Ekg showed normal sinus bradycardia.The patient underwent x-rays of the chest.Impression: old granulomatous disease.No acute process.(b)(6) 2009 the patient was discharged from the hospital.Discharge diagnoses: chest pain, not specified; history of seizure disorder; history of depression and anxiety.(b)(6) 2009 the patient underwent x-rays of the chest due to cough.Impression: no acute disease in the chest.(b)(6) 2009 the patient presented with the chief complaint of cough and congestion.Assessment: copd; chest pain, most likely musculoskeletal in etiology; coronary artery disease; hypertension.Chest x-ray showed no acute change.(b)(6) 2009 the patient was discharged from the hospital.Discharge diagnoses: copd exacerbation; coronary artery disease with status post cardiac stenting; trans abdominal hysterectomy.Chest x-ray showed no acute change.(b)(6) 2009 the patient presented with right hip pain due to a fall.The patient underwent ct of the lower extremity due to joint pain pelvis.Impression: unremarkable ct scan of the right hip.(b)(6) 2009 the patient underwent x-rays of the chest due to cough.Impression: no acute process.(b)(6) 2009 the patient presented with the admitting diagnoses of dehydration and gastroenteritis.The patient had diarrhea of 1 week with frequency and burning on urination.She also complained of cramping more on the right lower quadrant.Discharge diagnoses: dehydration; gastroenteritis urinary tract infection hematuria etiology: probably urinary tract infection copd.(b)(6) 2009 the patient underwent x-rays of the lumbar spine due to lumbago.Impression: normal views of the lumbar spine.(b)(6) 2009 the patient presented with right knee pain and underwent x-rays of the knee due to lower leg injury.Impression: normal views of the knee.(b)(6) 2009 the patient was admitted for chest pain with radiation into left arm.The patient underwent x-rays of the chest.Impression: no active disease in the chest; moderate emphysema and dextroscoliosis.(b)(6) 2009 the patient presented with the chief complaint of severe abdominal pain.The patient underwent x-rays of the abdomen.Impression: constipation, no obstruction; radiopaque density overlying the right l5 transverse process; prominent liver shadow.(b)(6) 2009 the patient underwent x-rays of the chest due to shortness of breath.Impression: old granulomatous disease.No acute process.(b)(6) 2009 the patient underwent x-rays of the chest due to chronic airway obstruct.Impression: no active disease in the chest.(b)(6) 2009 the patient presented with the complaint of cough.Assessment: copd exacerbation.Chest x-ray showed emphysema, no acute infiltrate.(b)(6) 2009 the patient presented with the complaint of dizziness.The patient underwent x-rays of the chest.Impression: no active disease in the chest.(b)(6) 2009 the patient presented with the chief complaint of cough, congestion and weakness.The patient was admitted for chills, fever, aches, pains and decreased appetite.Assessment: copd; systolic viral infection; coronary artery disease; hypertension.Chest x-ray showed emphysema, no acute infiltrate.(b)(6) 2010 the patient underwent x-rays of the chest due to chest pain.Impression: cardiomegaly, nothing acute; emphysema.(b)(6) 2011, (b)(6) 2011 she underwent x-rays of the chest due to chest pain.Impression: no active disease in the chest (b)(6) 2011 the patient presented with dull aching pain in left chest.She underwent x-rays of the chest due to chest pain.Impression: no active disease in the chest; granulomas around the left hilum (b)(6) 2011 the patient presented with pain in left arm radiating into left upper chest and left shoulder.She underwent x-rays of the chest due to chest pain.Impression: no active disease in the chest.(b)(6) 2011: patient presented with atypical chest pain.It started in the left arm and radiated to the left upper chest and left shoulder.Patient described it as burning sensation in arm and chest.Pain was intense at times.The pain would frequently wake her up from her sleep.She had associated shortness of breath, nausea, palpitations and lightheadedness.At times patient would be having shooting pain in head.Ecg revealed sinus bradycardia with a heart rate of 37.Impression: atypical chest pain, asymptomatic bradycardia, chronic obstructive pulmonary disease exacerbation is stable.Patient underwent echocardiogram.Interpretation: thickening of mitral valve leaflets.Normal chamber dimensions.Left ventricle is normal size with normal wall motion.Left ventricular ejection fraction 63 percent.Trace mitral regurgitation.Trace tricuspid regurgitation.Color doppler revealed trace of mitral and tricuspid regurgitation.(b)(6) 2011: patient was discharged with following discharge diagnoses: chest pain, most likely gastroesophageal reflux disease related.Copd.Status post transient ischemic attack.Anemia.(b)(6) 2011 chest x-ray showed patchy infiltrate right mid lower lung field and possible underlying lesion.(b)(6) 2011 the patient underwent ct of the chest due to pneumonia.Impression: alveolar pneumonia in the right upper lung field and consolidation also noted in the right lung base extending to the periphery.Minimal infiltrate in the lingula.(b)(6) 2011 the patient presented with local pain over the anterior chest wall and rib pain.She underwent x-rays of the chest due to chest pain.Impression: mild hyperinflation with central; scarring but no active process and with interval clearing of bilateral infiltrates.The patient underwent ultrasound study of the gall bladder due to right upper quadrant pain.Impression: negative examination.(b)(6) 2012: patient presented with chest pain.Patient stated that the pain was pleasure-like in nature.It was located in the left side of the chest and radiated to left arm and neck.Assessment: chest pain, unstable angina, hypertension, coronary artery disease, tobacco use.X-rays of the chest showed emphysema, no acute infiltrate.Patient underwent another chest x-ray.Impression: decreased inspiratory effort with borderline vascularity but overall no distinct active process in comparison with earlier examination of this same day.(b)(6) 2012: patient presented with chest pain.Patient had increasing dyspnea on exertion and suddenly started having anterior chest wall pains.Usually, they were very intense and radiated to the back.Ekg revealed sinus rhythm with intermittent sinus node exit block.Rate around 58.No ischemic changes.Impression: chest pain most likely unstable angina; copd; hypertension; hyperlipidemia.(b)(6) 2012: patient underwent left heart catheterization, left ventricular angiogram, selective coronary arteriogram due to indications of unstable angina.Impression: noncritical proximal lad disease about 30 to 40%.Normal lv function.(b)(6) 2012: patient was discharged with following discharge diagnoses: chest pain/unstable angina.Hypertension.Coronary artery disease.Chronic obstructive pulmonary disease.Hyperlipidemia (b)(6) 2012: patient presented with neck pain after motor vehicle accident.Assessment: anxiety state unspec, backache unspecified, chronic back pain, cervicalgia (b)(6) 2012 the patient complained of sternal chest pain with nausea, dyspnea, weakness, left arm and posterior back pain.The patient underwent x-rays of the chest due to chest pain.Impression: no active disease in the chest.(b)(6) 2012 the patient presented with the complaint of chest pain, dizzy and shortness of breath.The patient underwent x-rays of the chest due to chest pain.Impression: no active disease in the chest.(b)(6) 2012 the patient underwent xr bone densitometry due to osteoporosis.Impression: osteoporosis and risk of fracture (b)(6) 2013: patient underwent emg and nerve conduction study which demonstrated a subacute on chronic healing lumbar radiculopathy on the right affecting the l5 nerve root, which appears to possibly be causing a demyelinating peroneal neuropathy on the right.There was no evidence of an acute lumbar radiculopathy, diffuse peripheral polyneuropathy or sciatic neuropathy at the time of examination.Assessment: low back pain with right leg dysesthesia secondary to subacute on chronic lumbar radiculopathy.Diffuse back pain secondary to possible fibromyalgia versus a stain with myofascial pain.Osteoporosis with rib fracture on the left.(b)(6) 2013: patient presented with low back pain.Previous neuropathic pain in the right lower extremity was present but not so severe.Patient reported sensation which felt like spider is crawling down her leg extending from low back area to approximately the right calf.Patient experienced some radiating pain.Patient reported some numbness and tingling from time to time especially when she sat in certain positions.Emg and nerve conduction study demonstrated a subacute on chronic lumbar radiculopathy.Dexa scan was also performed, secondary to possible osteoporosis present and was found to be positive for osteoporosis and a high risk of fracture.Vitamin d level was noted to be low.(b)(6) 2013: patient presented with thoracic and low back pain.Recently, patient developed pneumonia and her pain had been increasing.Patient had some intermittent numbness and tingling but resolved.Patient noted 5 pound weight loss.Patient reported dizziness but this occurred with the most recent pneumonia.Low back review revealed positive faber on the right hand side, reproducing some right pelvic pain.There was some tenderness to palpation greatest in the right piriformis area, which is greater than the right si joint.Mid back review revealed diffuse tenderness to palpation throughout the thoracic area.Assessment: low back pain with right leg dysesthesia secondary to chronic lumbar radiculopathy with neuropathic pain.Diffuse back pain secondary to fibromyalgia versus myofascial pain from previous strain versus related most recent pneumonia.Osteoporosis with history of rib fracture on the left.(b)(6) 2013 the patient presented with the complaint of cough and dizziness.Assessment: bronchopneumonia, bilateral.X-rays of the chest showed bibasilar infiltrates worse than prior.(b)(6) 2013 the patient underwent x-rays of the ribs due to chest pain.Impression: bibasilar atelectasis.(b)(6) 2013 the patient was discharged from the hospital with the following diagnoses: bronchopneumonia, bibasilar; copd; nicotine de pendent; chronic low back pain; coronary artery disease; hyperlipidemia.X-rays of the chest showed small infiltrate left base.(b)(6) 2013: patient presented with left elbow and wrist pain with low back pain.Pain was more prominent on the right hand side.Patient noted that it was usually intermittent in nature and did tend to be present in the anterior thigh and lateral thigh.Patient noted that the pain in the elbow could radiate up to the shoulder area and down to the wrist area.There was some wrist pain as well with some numbness in the hands.Patient also reported some difficulty with grasping items.Per x-ray, there are some possible spots on lung.Assessment: decreased sensation with elbow and wrist pain, secondary to probable carpal tunnel syndrome and cubital tunnel syndrome on the left hand side.Low back pain with intermittent dysesthesia secondary to probable right piriformis strain, with an intermittent sciatic, complicated by a possible chronic radiculopathy.(b)(6) 2013 the patient underwent x-rays of the humerus due to pain in limb.Impression: normal views of the humerus.The patient underwent x-rays of the elbow due to joint pain.Impression: normal views of the elbow.The patient underwent x-rays of the left shoulder.Impression: no acute fracture.(b)(6) 2013 the patient presented with the chief complaint of shortness of breath.The patient also complained of dry cough, soa, and elevated temperatures x 4 days.The patient had productive cough with blood tinged sputum and complained of achy myalgias.The patient underwent x-rays of the chest due to soa.Impression: early infiltrate right base.(b)(6) 2014 the patient underwent x-rays of the chest due to chest pain.The mid chest pain was described as sharp in nature and with radiation into left arm.She also complained of dry non productive cough.Impression: no active disease in the chest.(b)(6) 2014: patient presented with chest pain.The chest pain started yesterday with tightness in the middle of the chest with radiation to the back and left arm.This was associated with shortness of breath.Patient also felt nauseated with these episodes of severe intensity pain.Impression: chest pain suggestive of angina.Hypertension, fairly well-controlled.Chronic obstructive pulmonary disease, stable.Hypercholestrolemia.Dyspnea.Chronic tobacco use.Coronary artery disease.History of calcified pulmonary nodule.Hemoptysis, mild.Patient underwent selective left coronary angiogram, selective right coronary angiogram and left ventriculogram due to indications of acute coronary syndrome.No immediate complications were noted.Impression: noncritical proximal left anterior descending (lad) coronary artery stenosis.Normal left ventricular (lv) function.Patient underwent echocardiogram.Interpretation: normal left ventricular size and function with no segmental wall motion abnormalities noted.'ejection fraction estimated at 60-65%.'mildly thickened aortic valve leaflets with no stenosis or regurgitation.Normal morphology mitral valve with mild mitral regurgitation.Normal tricuspid valve with mild tricuspid regurgitation.Normal pulmonic valve.Left atrium, right atrium, and right ventricle have normal size and function.No pericardial effusion noted.Doppler shows grade 1 diastolic dysfunction.(b)(6) 2014: patient was discharged home with following final diagnoses: unstable angina.Hypertension.Copd.Hyperlipidemia.(b)(6) 2014: patient underwent lumbar x-ray which demonstrated mild djd with hardware fusing l5-s1 and minimal slippage noted.(b)(6) 2014 the patient presented for a follow up on anxiety and chronic pain and reported constant head aches.Assessment: anxiety state, unspecified, insomnia.(b)(6) 2014: patient underwent ekg.(b)(6) 2014 the patient presented with contusion injury on left lateral chest wall.Unable to lay on that side and hurts when she coughs.X-rays of the chest and left ribs showed a number of sub acute left sided rib fractures.Assessment: essential hypertension; chronic obstructive lung disease; hyperlipidemia.(b)(6) 2014: patient presented with back pain.System reviews were positive for peripheral edema, shortness of breath, nausea, lower back tender, stiffness, pain, pre-syncope, anxiousness, depressed mood, fatigue.Assessment: cerumen impaction; anxiety state, unspecified.(b)(6) 2014: patient presented for follow up on hypertension.(b)(6) 2014: patient presented with the problem of tightness in chest.Patient underwent chest x-ray.Impression: emphysema.No acute process.(b)(6) 2014 the patient underwent chest x-ray.Impression: emphysema no acute process.(b)(6) 2014: patient presented for follow up with lymph on right side of neck.(b)(6) 2014: patient underwent ekg.(b)(6) 2014 the patient presented with the complaints of shortness of breath, bronchitis and bronchospasm.The patient underwent chest x-ray due to soa.Impression: possible developing nodule right base ct scan suggested rule out nodule or neoplasm acute infiltrate.(b)(6) 2014: patient presented for follow up with chronic back pain.(b)(6) 2014 the patient was admitted with the diagnosis of pneumonia, right middle lobe.The patient had shortness of breath, cough and pain on the right side of the chest.Discharge diagnoses: pneumonia, right middle lobe.Lesion on the right lower lung zone (mucous plugging versus neoplasm).Chronic obstructive pulmonary disease.Nicotine dependence.Patient underwent chest x-ray.Impression: emphysema.The patient underwent ct of the chest due to right lower lung nodule vs mass.Impression: patchy pneumonia in the right middle lobe with a defect on the right lower lobe could be mucus plugging versus filling defect.(b)(6) 2014 the patient was admitted to er with the diagnosis of chronic obstructive pulmonary disease exacerbation.The patient had cough, congestion, weakness x 3 days and fever.The cough was associated with chills, fever aches and pain.The sputum is yellowish in color.She continued to have pain in her lower back even after surgery.She also has pain in right shoulder and other joints.There was tenderness in her lower back with a scar from previous surgery.Chest x-ray showed emphysema and no acute process seen.(b)(6) 2015: patient presented for follow up with back and leg pain.Patient reported some intermittent burning in right medial thigh on occasion.Pain was located in right buttock and right lateral ankle/calf.The pain was constant dull ache in buttock and intermittent in new right lateral ankle pain described as burning.Prolonged sitting, twisting and prolonged standing, walking aggravated the pain.Assessment: low back pain and right buttock pain secondary to piriformis syndrome superimposed upon chronic radiculopathy with neuropathic pain.Depression-improved.Ischemic heart disease with history of mi.History of osteoporosis.(b)(6) 2015 the patient complained of mid sternum chest pain with radiation into left shoulder.The pain was sharp and dull.The patient also complained of soa as well.Patient underwent chest x-ray.Findings: no active disease in the chest.(b)(6) 2015: patient presented with chest pain and palpitations.Patient described it as her heart flip-flopping and sometimes even stopping, and around that time she started having tightness in her chest, sometimes it radiated in the left arm and sometimes to the back.Ekg showed normal sinus rhythm, nonspecific interventricular conduction delay.Impression: chest pain, some typical and atypical features noted.Cardiac enzymes are negative so far.No acute ischemic changes noted.Palpitations.Tobacco use.Patient underwent chest x-ray.Findings: there is no active, cardiopulmonary disease.There is no effusion.Copd is noted.Patient underwent echocardiogram due to diagnosis of intermediate coronary syndrome.Summary: mitral valve: normal, prominent a-wave aortic valve: normal, tricuspid valve: normal, mild tricuspid regurgitation pulmonic valve: normal (b)(6) 2015: patient was discharged in stable condition with discharge diagnosis of angina pectoris.Hypertension.Hypercho lesterolemia.Chronic obstructive pulmonary disease.(b)(6) 2015 the patient presented with the complaint of chest pain.The pain was mild and dull aching with radiation into left shoulder.The patient underwent x-rays of the chest.Impression: no active disease in the chest.(b)(6) 2015: patient presented with chest pain and intermediate coronary syndrome.(b)(6) 2015: patient presented for follow up with chronic pain and hypertension.Assessment: chronic pain; other unspecified secondary hypertension.(b)(6) 2015: patient presented for follow up with low back pain.Assessment: anxiety state, unspecified; chronic back pain.(b)(6) 2015: patient presented for follow up with back pain.(b)(6) 2015: patient presented with low back pain and right leg pain, numbness.Right leg numbness felt more intense but radiating pattern unchanged to patient.Pain was located at right buttock and right calf/foot.There was constant dull ache in buttock and intermittent burning in right lower leg.Pain was radiating from right buttock down to foot.Prolonged sitting, twisting and prolonged standing, walking was aggravating the pain.Numbness/tingling were intermittent with activity.Assessment: low back pain and right buttock pain secondary to piriformis syndrome/sij pain syndrome superimposed upon chronic radiculopathy with neuropathic pain.Depression-stable ischemic heart disease with history of mi.History of osteoporosis.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on, (b)(6) 2009: as per the bolling records, patient presented for an office visit.On (b)(6) 2013: as per the billing records, patient came for an office visit.On (b)(6) 2014: patient presented for an office visit.On (b)(6) 2015: patient presented for follow up with back pain.Assesment: anxiety, chronic back pain.
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
anglin greg
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key4215466
MDR Text Key16303031
Report Number1030489-2014-04181
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/01/2012
Device Catalogue Number7510800
Device Lot NumberM110821AAA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/29/2015
Initial Date FDA Received10/30/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Not provided
Supplement Dates FDA Received04/13/2015
05/06/2015
06/19/2015
07/15/2015
12/01/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/20/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight48
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