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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 Asthma (1726); Chest Pain (1776); Contusion (1787); Cyst(s) (1800); Dyspnea (1816); Edema (1820); Fever (1858); Headache (1880); Hematoma (1884); Herpes (1898); Inflammation (1932); Irritation (1941); Nausea (1970); Neuropathy (1983); Pain (1994); Rash (2033); Scarring (2061); Swelling (2091); Tachycardia (2095); Vomiting (2144); Weakness (2145); Dizziness (2194); Dysphasia (2195); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Discomfort (2330); Depression (2361); Numbness (2415); Respiratory Tract Infection (2420); Skin Inflammation (2443); Sweating (2444); Chest Tightness/Pressure (2463); Low Oxygen Saturation (2477); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651)
Event Type  Injury  
Manufacturer Narrative
(b)(6).(b)(4).Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
Event Description
It was reported that on an unspecified date, pt had placement & removal of harrington rods.On an unspecified date in 1980, the pt underwent t12-l3 posterior spinal fusion with then subsequent implant removal in the 1980s with post implant removal coronal & sagittal imbalance.On an unspecified date in 1983, pt received a posterior spinal instrumented fusion.On an unspecified date in 1984, implants were removed.On (b)(6) 2010: pt presented with the following pre-op diagnosis: history of remote posterior spinal fusion with removal of instrumentation for idiopathic scoliosis.Degenerative lumbar scoliosis.Multilevel lumbar scoliosis.Multilevel lumbar instability.Lumbar spinal stenosis.Lumbar neuritis.Pt underwent post l2 pedicle subtraction osteotomy with t3 to the sacrum & pelvis posterior spinal fusion, with lateral inter-body fusion performed at l3-4 & l4-5 & tlif at l5-s1.She underwent the following procedures: l3-l4, l4-l5 xlif with l5-s1 tlif & placement of bilateral iliac screws.No complications were reported.She also underwent the following procedures: l3-l4, l4-l5 anterior spinal fusion via left sided transpose approach.Insertion of interbody implant, l3-l4 & l4-l5.Morselized allograft.Pre-op notes: a left sided transpose approach was then carried out to l3-l4 interspace.Diskectomy was then carried out & a size 8 coronet nuvasive coronet cage was placed at l4-l5.These cages each had two sheets of bone morphogenic protein.Pt presented with the following pre-op diagnosis: history of adolescent idiopathic scoliosis status post remote posterior spinal fusion with subsequent implant removal performed remotely.Sagittal imbalance.Coronal imbalance.Kyphoscoliosis.Lumbar instability.Lumbar spinal stenosis.Lumbar radiculopathy & neuritis.Procedure: exploration fusion mass confirmed pseudoarthrosis l3-4, l4-5.Posterior segmental instrumentation l5 to the sacrum & pelvis.Posterior spinal fusion l5-s1.Pelvic fixation other than sacrum.Pedicle screws were placed at l5-s1 & pelvis.After placing the screws radiographs in ap & lateral plane showed good alignment of the screws.A short rod was then cut & contoured & the l5 through the sacrum & pelvis regions were then secured into place.Final radiographs confirmed good alignment of the implants & the spine.On (b)(6) 2010: pt presented with back pain.Pt was presented with the following pre-op diagnosis: adolescent idiopathic scoliosis.Kyphosis.Degenerative scoliosis.Lumbar spinal stenosis.Radiculopathy.Lumbar instability with lateral listhesis.Procedure: exploration of the fusion mass with confirmed nonunion l2-l3 & l3-l4.L5-s1 transforaminal lumbar interbody fusion.Insertion interbody implant l5-s1.Laminectomy & decompression l1-l2 & l2-l3 with decompression of l2 & l3 nerve root central, in the foramen, & in the lateral recess.Smith - petersen osteotomy l1-l2 & l2-l3.Partial corpectomy via posterior transpedicular approach at l2 including pedicle subtraction of l2.T3 to the sacrum & pelvis posterior spinal fusion.T3 to the sacrum & pelvis posterior spinal fusion.Posterior pelvic fixation of the sacrum.Local autograft.Morselized allograft.Interpretation radiographs x8 hours.Implants: titanium screws with cobalt chrome rod.Carbon fiber interbody implant l5-s1.Pre-op notes, the fusion mass from t11 down to l3 & l4 were exposed, cleared free of soft tissue & non-union was confirmed that l2-l3 & l3-l4.A size 10 carbon fiber interbody cage was placed at l5-s1.The cage & disk space were filled with local autograft & two sheaths of rhbmp-2/acs.The pedicle screws were placed bilaterally from t12 to t3.A right sided pedicle screw was placed at l1 & then bilateral pedicle screws at l3, l4, l5, s1, & the pelvis.During the corpectomy & osteotomy procedures holding rods were maintained in place to maintain the stability across the spine.Maneuvers were then carried out across the holding rods & a left sided rod was cut & contoured laid into place.Radiographs ap & lateral planes confirmed good alignment of the implants & the ap & lateral planes, it was decorticated & local autograft & morselized allograft were placed across the decorticated posterior elements.Additionally, two large kits of bone morphogenic protein were laid across the decorticated posterior elements.The rods were locked into place.Final radiographs ap & lateral planes showed good alignment of the spine.Pt underwent t3 to pelvis posterior spinal fusion & l2 osteotomy using rhbmp-2/acs bone graft.Four 5x35 screws, four 6x40mm screws, eighteen 6x40mm screws of different model number, & thirty-five 6x40mm screws of different model number were implanted.Two bone graft substitute were used.Seven hemostatic matrix was used during the operation.Two set screw, two rod, one cross link, one 5 degree.Dbm putty was used.All implants to posterior spine.No complications were reported.On (b)(6) 2010: pt presented for eval of right shoulder pain.Past medical history is significant for severe thoracolumbar kyphoscoliosis.Assessment: right posterior thoracic strain this is superimposed on relatively recent extensive dorsal spine surgery directed at correcting severe kyphoscoliosis.There is no clinical evidence to suggest compromise of the spinal fusion.On (b)(6) 2010: the pt underwent x-rays of the chest due to cough, shortness of breath & congestion.Impression: negative for acute pulmonary process.Interval correction of scoliosis with posterior fusion hardware.On (b)(6) 2011: pt presented with left greater than right lower extremity edema & pain.She states that she occasionally feels short of breath.Neck: supple with no lymphadenopathy or thyromegaly.Back: no pain on palpation to the posterior thorax.The pt underwent venous duplex ultrasound of bilateral legs due to bilateral lower extremity pain.Opinion: no evidence of deep venous thrombosis in the legs.On (b)(6) 2011: pt presented with a history of severe congenital kyphoscoliosis.Assessment: well adult female.Depression, exogenous & reactive.Chronic thoracolumbar spine disease.Status post-surgical correction with an excellent response.New left sacroiliac joint pain.Status post-surgical menopause with diminished libido; pt would like to address that issue.On (b)(6) 2011: the pt underwent x-ray of the chest due to chest pain.Impression: no acute consolidation.On (b)(6) 2011: pt presented with posterior thorax demonstrates a midline scar over the dorsal spine, well-healed.Assessment: right chest wall pain.Query pleurisy.Query atypical herpes zoster.On (b)(6) 2011: the pt underwent ct angiography of the chest due to right-sided pleuritic chest pain & shortness of breath.Impression: mild scar inferior lingual, no acute appearing infiltrate.Mild chronic biliary dilation.On (b)(6) 2011: pt presented for follow up.Chest: deformities from longstanding pronounced kyphoscoliosis & surgical correction are stable.She continues to have a considerable right-sided scoliosis.Lungs are clear.There is mild tenderness over the left & right bases.No pleuritic friction rub is audible.Assessment: query suppurative bronchitis versus community acquired pneumonia in a somewhat compromised individual secondary to kyphoscoliosis & surgical treatment there of (restrictive lung disease).On (b)(6) 2011: pt presented for follow up.Chest: healed surgical scar.Rightward rotatory scoliosis in the mid-thorax.Lungs are clear with good entry in all fields.There is no pleural friction rub.There is mild to moderate tenderness in the mid-axillary to anterior axillary line on the right at the 7th & 8th ribs.Assessment: persistent pleuritic chest pain with suppurative bronchitis.The pt underwent x-ray of the chest due to cough.Impression: no radiographic evidence for acute cardiopulmonary disease.On (b)(6) 2011: pt presented with f/u.Assessment: persistent right chest pain, previously thought to represent pleurisy.It seems this is quite possibly a symptomatic manifestation of known cholelithiasis.On (b)(6) 2011: pt presented for f/u.Neck veins are flat.Assessment: recent cholecystectomy.Intraoperative cholangiogram, ercp & sphincterotomy day following surgery.On (b)(6) 2011: the pt underwent ct of the abscess drainage peritoneal.Opinion: successful ct-guided drainage of a fluid collection in the gallbladder fossa.On (b)(6) 2011: the pt underwent "er" biliary ductal system due to bile leak.Impression: leak from gallbladder bed or a leaking duct of luschka.On (b)(6) 2011: the pt underwent ct of abdomen due to biloma.Impression: interval decrease in size of the fluid collection in the gallbladder fossa following drainage catheter placement.Residual inflammatory change within the right upper quadrant.Bibasilar atelectasis.Mild right-sided hydronephrosis of uncertain etiology.On (b)(6) 2011: pt presented for f/u.Pt presented with abd pain, nausea, vomiting.Assessment: persistent right upper quadrant pain following cholecystectomy & subsequent bile fluid collection in the right upper quadrant.Status post ercp & stenting, status post drainage of right upper quadrant fluid collection.Persistent nausea & intermittent fever.(b)(6) has now been off antibiotics for about 7 days.She appears non-toxic; although she complains of discomfort, she is moving about fairly well in the office.On (b)(6) 2011: the pt underwent abd ultrasound due to pain & fever.Impression: decreasing size of the complex collection in the gallbladder fossa consistent with resolving biloma or hematoma.On (b)(6) 2011: pt presented with follow up.Assessment: persistent abd pain post cholecystectomy & common duct ercp.Mild, persistent lipase elevation.On (b)(6) 2011: pt presented for f/u.Pt presented with right upper abd pain.Back: she has healed surgical scars from previous spinal fusion from the base of the cervical spine to the lumbosacral junction.Chest x-ray: normal lung marking; spinal fixation hardware is noted.Persistent pain, right upper quadrant, with dyspnea; etiology uncertain.Six weeks post laparoscopic cholecystectomy & about 5 weeks post catheter drainage of fluid in the gallbladder bed.No current clinical evidence of major infection.On (b)(6) 2011: the pt underwent abd ultrasound due to probable biloma.Impression: slight decrease in size of complex collection inferior to the liver consistent with hematoma or biloma.Stent within the donor common bile duct.New dilation of pancreatic duct.On (b)(6) 2011: the pt underwent "ercp" due to right upper quadrant pain.Impression: prior cholecystectomy with normal ercp; mild biliary prominence is present.On (b)(6) 2011: the pt underwent ct of the chest due to question biloma.Impression: cholecystectomy.On (b)(6) 2011: pt continues to have upper quadrant & right posterior thoracic pain.Back: dorsal spinal contour is post-surgical from an extensive surgical procedure to address severe kyphoscoliosis.There is no focal tenderness to the back.There is mild tenderness in the posterior axillary line at the costal margin.There is no crepitus.Assessment: status post recent cholecystectomy with stent placement & successful removal.She appears to be recovering well from that illness & the surgical procedures which addressed it.Persistent abd bloating & pain.Right flank pain.Previous thoracic spine surgical correction with indwelling hardware.Query contributor to the pt's pain syndrome.On (b)(6) 2011: pt presented for f/u.Pt has lower chest pain.Neck veins are flat.Carotid upstroke: volume is full & equal.Extremities: well-perfused with no edema.Assessment: chest pain; etiology uncertain.The transient chest pain resolving completely over about an hour to an hour & a half argues against significant thromboembolic phenomenon.Additionally, she is 3 weeks out from her surgical procedure.On (b)(6) 2011: the pt underwent stress echocardiography, which was normal.On (b)(6) 2011: pt presented for f/u.Assessment: multiple medical problems as above, stable.Recovering from complicated cholecystectomy with common duct stenting & extraction of common duct stones.On (b)(6) 2011: the pt underwent ct of lumbar spine due to scoliosis surgery & evaluated for bony mass.Impression: unchanged surgical fusion of the lumbar spine & scoliosis.Moderate diffuse osteopenia with minimal lateral wedging of the l2.She also underwent mri of lumbar spine.Impression: new hardware fusion of the visible thoracic, lumbar & sacral spine is associated with a new l5 laminectomy & there is no evidence of complication.Ct of the thoracic spine was also done.Impression: new posterior hardware fusion & bone graft fusing the posterior elements.Mild to moderate diffuse osteopenia; no significant bony encroachment on the thoracic canal or foramina.On (b)(6) 2011: the pt presented with f/u visit.The pt complained of numbness in right arm, headache.Neurologic examination revealed tight hamstrings bilaterally & diminished sensation over the right thigh as well over the medial & lateral aspects of the right foot.Ct scan was reviewed which showed good alignment of the spine & implants.Imaging of the cervical spine showed no cervical stenosis & no evidence of stroke or tumor.Assessment: residual sagittal imbalance status post l2 pedicle subtraction osteotomy with intermittent fatigue.Recent bout with pancreatitis due to complications from cholecystectomy.On (b)(6) 2011: pt presented for eval of abd pain.She describes pain in the right upper quadrant & right lower quadrant & left lower quadrant.Neck: supple.No mass or adenopathy.Assessment: recurrent abd pain; this is about 10 weeks post a complicated cholecystectomy.On (b)(6) 2011: the pt underwent abd ultrasound due to prior cholecystectomy.Impression: prior cholecystectomy with mildly prominent common bile duct; no intrahepatic biliary dilation to suggest obstruction.On (b)(6) 2011: pt presented for f/u.Neck veins are flat.Carotid upstroke: volume is full & equal.Chest: 'there is a surgical scar over the dorsal midline from tl to l5 with no focal tenderness.Lungs are clear with fair excursion & good entry.On (b)(6) 2011: the pt underwent ct scan of the abdomen & pelvis, which showed dilation of the common bile duct up to 12mm.She was also noted to have a sub-centimeter low attenuation lesion that was likely consistent with a simple cyst.On (b)(6) 2011: the pt presented for f/u & complained of right upper quadrant abd & right flank pain.She stated that it was getting worse rather than better.Assessment: persistent right upper quadrant abd & right flank pain; etiology uncertain.On (b)(6) 2011: the pt presented with abd pain.The pt underwent unknown examination.Impression: long standing history of generalized abd discomfort.A 7cm low attenuation lesion in the liver, likely a simple cyst.On (b)(6) 2011: the pt presented with skin lesion on the right thigh.The pt underwent diuretic renal scintigraphy due to renal obstruction.Impression: split renal function.Right-sided pelvocaliectsis with post lasix parameter in the low indeterminate range for obstruction, no high-grade obstruction in the right kidney.On (b)(6) 2011: the pt underwent ct of the abdomen & pelvis due to right sided abd pain.Impression: no acute abnormality.Prior removal of gall bladder with mild secondary intra & extrahepatic biliary dilation.On (b)(6) 2011: the pt presented with pain in the left upper quadrant of the abdomen.This was a dull aching pain that was at times slightly improved with food.It radiated into the retrosternal mid-anterior chest with radiation into the left shoulder.Assessment: persistent & migrating abd pain.Retrosternal pain.On (b)(6) 2011: the pt presented for an office visit & complained of symptoms suggestive of respiratory tract infection.Assessment: "uri".12/09/2011: the pt underwent x-rays of the chest due to cough.Impression: no radiographic evidence for acute cardiopulmonary disease.On (b)(6) 2011: the pt underwent electrocardiography due to chest pain & tachycardia.Summary: normal biventricular function.Normal chamber size.Trivial tricuspid regurgitation with normal pulmonary pressures.On (b)(6) 2011: the pt complained of shortness of breath, cough & chest pain.Assessment: post upper respiratory infection, irritation, inflammation or possible allergic reaction to environmental exposure.On (b)(6) 2012: the pt presented with chest pain & left upper quadrant abd pain.Assessment: continued chest discomfort with hypoxemia.History of severe congenital kyphoscoliosis.The pt underwent lung "nm" due to shortness of breath.Impression: very low probability of pulmonary embolism.She also underwent chest x-rays.Impression: no radiographic evidence for acute cardiopulmonary disease.On (b)(6) 2012: the pt underwent ct of chest due to left lower quadrant abd pain.Impression: no acute thoracic or abd abnormality.Mild right pelvocaliectsis.Intra & extrahepatic biliary ductal dilation.Indeterminate pulmonary nodules within the right upper lobe measuring up to 6mm in size.On (b)(6) 2012: pt presented for f/u of dyspnea.Impression: severe combined restrictive & obstructive pulmonary disease in the setting of: kyphoscoliosis status post surgery.Possible underlying element of asthma or airway hyperreactivity.No obvious parenchymal lung disease from previous cat scan reports.Resting tachycardia with normal echocardiogram.The pt had a previous history of "hyperthyroidism." i do not know if this is instrumental.Obviously, a concern with this degree of lung disease would be secondary pulmonary hypertension, but with a normal rv systolic pressure, we do not have evidence of this.History of abd pain & discomfort.Nonspecific pulmonary nodules, which will need to be followed.On (b)(6) 2012: pt presented for f/u of dyspnea on exertion & pulmonary nodules.The reduced total lung capacity probably is related to her harrington rods.Impression: dyspnea primarily on the basis of uncontrolled asthma.Mild elevation of liver functions that will need f/u.Small nonspecific pulmonary nodules.I would recommend f/u in on (b)(6) 2013.Mild restrictive pulmonary abnormality secondary to kyphoscoliosis, status post harrington rod placement.On (b)(6) 2012: the pt presented with chest pain.On (b)(6) 2012: the pt presented for f/u with abd pain that was across the upper abdomen in the costal margin.The pain was described as sharp & cramping.Assessment: restrictive obstructive lung disease.Congenital spine deformity.Abd pain.On (b)(6) 2012: radiographs obtained demonstrate implants are intact.Has 36 degrees of lumbar lordosis.Pelvic incidence 64 degrees.Pelvic tilt 36 degrees, lumbar lordosis at 28 degrees.Sva 65 mm.Assesment: two years post-operative.Residual sagittal malalignment.Poorly controlled asthma.On (b)(6) 2012: the pt presented for f/u with blood pressure check.Assessment: hypoxia; asthma; bronchopneumonia; cp.The pt underwent chest x-rays due to chest pain.Impression: no radiographic evidence for acute cardiopulmonary disease.On (b)(6) 2012: the pt presented with dyspnea & chest pain.Electrocardiography was done which revealed normal blood pressure with response to exercise, negative ecg stress test for ischemia.On (b)(6) 2012: the pt presented for f/u with continuous intermittent dyspnea.Assessment: dyspnea.Spine pain currently adequately controlled.On (b)(6) 2012: pt presented for f/u of her asthma.Chest: no wheezes, rales or rhonchi.Breath sounds are slightly diminished.Cardiac: no s3 or s4, extremities show no edema.Impression: asthma, still not adequately controlled with fev1 of 68% of predicted & asthma control test of 14.History of kyphoscoliosis, status post reconstructive surgery.Hypoxemia, currently resolved.Previous history of right upper quadrant discomfort.Problem resolved.On (b)(6) 2012: the pt presented for f/u with multiple erythematous, erupting lesions of the skin in remote locations.The most prominent was in the mid-tight shin, mid-tibial region.Assessment: query infective versus autoimmune dermal lesions.On (b)(6) 2012: the pt presented for f/u with open sores, most prominently a raised open sore on the mid-right tibia that suggested an ulcerated vasculitis or erythema nodosum type lesion.Assessment: atypical lower extremity dermatitis/cellulitis.On (b)(6) 2012: pt presented for f/u.Pt presented with neck pain as well as right leg pain.On (b)(6) 2012: pt presented for f/u of her asthma cough & the ocular & pulmonary symptoms seem to be greatest.Chest: a very faint end-expiratory wheeze can be heard.Cardiac: p2 is not increased.Impression: asthma with mild exacerbation.Restrictive lung disease.Kyphoscoliosis.History of hypoxemia, which has improved.A history of epigastric discomfort, more so now than right upper quadrant pain.On (b)(6) 2012: the pt presented for f/u with persistent right upper quadrant abd pain.Assessment: recurring abd pain.Query peptic ulcer disease.Query proximal structure in the small bowel.Query intermittent incomplete small bowel obstruction.On (b)(6) 2012: the pt underwent ct of the abdomen & pelvis due to right upper quadrant pain.Opinion: the common bile duct is prominent.Fatty atrophy of the pancreas.The right renal pelvis is mildly prominent but the calyces are intact.Copious stool seen at the right colon consistent with constipation.On (b)(6) 2012: the pt presented with pain in stomach & pain in left hip & leg.Assessment: persistent right upper quadrant/right flank pain.Right cva tenderness with pyuria.Query insipient pyelonephritis.On (b)(6) 2012: the pt presented for f/u.She continued to have some chest tightness especially anterior with coughing or deep breathing.She had restrictive lungs due to her severe spinal scoliosis.On (b)(6) 2012: pt presented for f/u.Impression: combined obstructive restrictive abnormality from kyphoscoliosis & asthma.Right upper quadrant pain, probably related to irritable bowel, associated with constipation.Recent eval in the emergency room showing no evidence of myocardial ischemia or pulmonary emboli as a cause for chest discomfort.Suspect elements of esophageal dysmotility & spasm.On (b)(6) 2012: pt presented for f/u.Radiographs obtained demonstrate implants are intact.Has 36 degrees of lumbar lordosis.Pelvic incidence 65 degrees.Pelvic tilt 38 degrees.Sacral slope 35 degrees.Thoracic kyphosis 30 degrees.Sva 85 mm.Assesment: residual sagittal malalignment, status post l2 pedicle subtraction osteotomy & t3 through the sacrum & pelvis posterior spinal fusion.On (b)(6) 2012: the pt presented for f/u with ongoing flank to right lower quadrant abd pain with radiation in the inguinal region.Assessment: persistent right flank pain.Chronic constipation.On (b)(6) 2012: the pt underwent ct of abdomen & pelvis due to right flank pain & occult hematuria.Impression: mild prominent of the intra & extrahepatic bile ducts.Fatty infiltration of the pancreas.Prior cholecystectomy & hysterectomy.Moderate right hydronephrosis of uncertain etiology.The distal right ureter is not as well opacified as the left.The pt also underwent x-rays of the abdomen due to right flank pain.Impression: poor opacification of the distal right ureter.Moderate right hydronephrosis of uncertain etiology.On (b)(6) 2012: the pt underwent mri of the abdomen due to biliary dilation question obstruction.Impression: stable dilation of common bile duct greater than pancreatic duct; no visible stone; stenosis or a very small obstructing lesion at the annula itself.On (b)(6) 2012: the pt presented for f/u with right upper quadrant abd pain, occasional nausea, & pleuritic component of pain.The pain also radiated across the epigastrium to the left upper quadrant.It also radiated in a line along the 9th & 10th thoracic dermatomes on the right to the mid-posterior thorax.Assessment: chronic abd pain syndrome.Back pain.On (b)(6) 2012: pt presented for f/u.Pt presented with some residual back pain.Assessment: two & half years post-operative.History of cholecystectomy with postoperative pancreatitis.Chronic asthma.On (b)(6) 2012: the pt presented for f/u with pain in the right flank & dyspnea.Assessment: restrictive lung disease.This is likely largely secondary to congenital thoracolumbar kyphoscoliosis.Chronic back & abd pain.New skin lesions, right lower extremity.Likely focal cellulitic process.On (b)(6) 2012: pt presented for f/u of her asthma & her restrictive lung disease from kyphoscoliosis.She complains of some problems with breathlessness.Her chest exam reveals soft bibasilar crackles.She has diffuse mild abd tenderness.Diagnostic impression: increasing breathlessness, which i think is probably multifactorial, but i am concerned now about a cardiac etiology.Certainly her exam would suggest cardiac decompensation with rales on gallop.Asthma is certainly not adequately controlled with an fev1 of only 49% of predicted.Hypoxemia which is primarily nocturnal & related to her combined obstructive/ restrictive disease, the restrictive component coming for her kyphoscoliosis.The pt underwent x ray of the chest region.Impression: no radiographic evidence of pneumonia.Dual posterior fixation rods, thoracic & lumbar spine.On (b)(6)2012: the pt underwent routine c-echo test.Impression: left ventricular systolic function is hyperdynamic.Borderline rv systolic dysfunction.Right ventricular systolic pressure is normal.On (b)(6) 2012: the pt presented for f/u.Assessment: recent episode of altered consciousness, as above; etiology uncertain.History of severe thoracolumbar scoliosis status post-surgical repair.History of severe restrictive lung disease & associated hypoxemia.Questionable history of reactive airways disease.On (b)(6) 2012: the pt underwent ct of head due to blurred vision.Impression: no intracranial abnormality.No stroke, space-occupying lesion seen.On (b)(6) 2012: the pt presented with excessive sleep.On (b)(6) 2012: pt presented for f/u.Assesment: two & one half years post-operative.Chronic asthma.Echocardiogram indicates hyperdynamic left ventricular function, borderline rv dysfunction & normal right systolic pressure.On (b)(6) 2012: the pt presented with recurrent right upper quadrant abd pain.Ct scan of the head was reviewed which was negative for any evidence of intracranial injury or bleed.Assessment: recurrent right upper quadrant abd pain, etiology uncertain.Congenital spine disease.Chronic depression.Restrictive lung disease.On (b)(6) 2012: the pt presented for f/u with varying blood pressure.She was symptomatic in both extremes with headaches, nausea, sweating, dyspnea, & lightheadedness.Assessment: multifactorial compromise of respiratory function.Restrictive lung disease.Reactive airways disease.Chronic mild hypoxia.Query sleep apnea syndrome.(b)(6) 2013: pt presented for f/u.Assesment: 3+ years post-operative.Residual sagittal malalignment.Chronic asthma.Recent chest pain with abnormal ekg.On (b)(6) 2013: the pt presented with chest pain & fluctuations in blood pressure.She also had complaints of dyspnea, nausea.Neck was supple.Chest was moderate dextroscoliosis.On (b)(6) 2013: the pt presented with right arm pain.She developed pain & swelling at the site of the phlebotomy with proximal pain stranding up the medial aspect of the right biceps.Assessment: right arm cellulitis.Query brachiocephalic vein thrombophlebitis.On (b)(6) 2013: the pt presented with shortness of breath.Assessment: dyspnea.The pt underwent x-rays of the chest due to shortness of breath.Impression: no radiographic evidence for acute cardiopulmonary disease.On (b)(6) 2013: pt presented for f/u.Pt presented with the complaint for increasing breathlessness & cardiac etiology.The x-ray showed no acute diseases.The pt continues to have the complaint of right upper quadrant pain.She said this occurred after an episode of coughing.It is a more problem with movement of right arm & chest wall & if she coughs or sneezes.Impression: combined obstructive/restrictive abnormality.The restriction is on the basis of her kyphoscoliosis & the obstruction on the basis of asthma.Query nocturnal hypoxemia.This needs additional re-evaluation.History of palpitations.Suspect the pt may be having supraventricular tachycardia versus atrial flutter or atrial fibrillation.This needs more eval with a holter monitor.Severe dyspnea on exertion, which seems disproportionate to her findings, especially since pulmonary function & vital signs are the best that i have measured.I will recommend cardiopulmonary exercise testing with continuous laryngoscopy since she feels throat closure is occurring with exercise.On (b)(6) 2013: pt presented with dizziness, short of breath, chest tightness, chest pain.On (b)(6) 2013: the pt presented with right leg pain.She had pain & swelling along the course of the greater saphenous vein from just above the knee to the anteromedial aspect of the ankle on the right side.She also had worse pain with ambulation.Assessment: right leg pain, unknown etiology.History of chronic lung disease.The pt underwent ultrasound venous duplex of right leg due to redness & swelling.Impression: normal venous doppler ultrasound with no findings of dvt.On (b)(6) 2013: pt presented for f/u.Pt presented with severe pain from neck down to her tailbone, has residual sagittal malalignment as per pelvic parameters.Pt underwent x-ray which reveals that ap/lateral scoliosis views demonstrate intact implants.Continues to have sagittal malalignment.Assesment: 3+ years post-operative.Residual sagittal malalignment.Chronic asthma.Chronic pain.On (b)(6) 2013: pt underwent x-rays of the chest due to chest pain.Impression: mildly low lung volumes.On (b)(6) 2013: pt presented for f/u.Pt presented with back pain, facial numbness, right sided upper & lower extremity weakness & numbness & having likely a tia.Pt underwent ct scan of the thoracic & lumbar spine which shows solid arthrodesis from t3 through s1.Shows pso at l2.Assesment: residual sagittal malalignment.On (b)(6) 2013: pt underwent ct scan of the thoracic & lumbar spine.Impression: thoraco-lumbar posterior & lumbar anterior surgical fusion unchanged from comparison on (b)(6), 2011.Degenerative findings are also stable in the presence of mild to moderate osteopenia.On (b)(6) 2013: the pt presented for f/u.Assessment: recent cryptogenic thalamic tia.Stable at this point.On (b)(6) 2013: the pt presented for f/u.Assessment: recent cryptogenic thalamic tia.Persistent l lateral rectus m.Palsy.On (b)(6) 2013: pt underwent mri & ct scan of the head & neck region.On (b)(6) 2013: the pt presented for f/u.Assessment: recent episode of facial palsy & cross-over major motor deficit, recovered.Query highly atypical migraine syndrome.Intolerance to topiramate.On (b)(6) 2013: the pt presented with blood in stool.Assessment: query atypical migraine.Hemorrhoids, internal & external.On (b)(6) 2013: the pt presented with pleuritic chest pain on the left at the site of impact in the lower anterior left chest wall.Assessment: chest wall contusion.Query secondary bronchitis.On (b)(6) 2013: pt presented for f/u.Radiographs obtained demonstrate implants are intact.Has 31 degrees of lumbar lordosis.Pelvic incidence 66 degrees.Pelvic tilt 37 degrees.Pi-ll is 35 degrees.Thoracic kyphosis 30 degrees.Sva 96 mm.On (b)(6)2013: the pt presented with hurting in right side.She also complained of back pain & headache.Neurologic examination dizziness, light headedness, facial weakness, speech difficulties.On (b)(6) 2014: the pt presented with spots/rash on arms & stomach.
 
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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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5032417
MDR Text Key24701650
Report Number1030489-2015-02092
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
Reporter Occupation Attorney
Report Date 07/27/2015
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 Date04/01/2012
Device Catalogue Number7510800
Device Lot NumberM110809AAE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/26/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/24/2009
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) Required Intervention;
Patient Weight70
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