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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 7510600
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Asthma (1726); Cellulitis (1768); 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); Bronchopneumonia (2437); 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: (b)(6) 2010: patient presented with back pain.Patient was presented with the following pre-op diagnosis 1) adolescent idiopathic scoliosis.2) kyphosis 3) degenerative scoliosis.4) lumbar spinal stenosis.5) radiculopathy.6) lumbar instability with lateral listhesis.Procedure: 1.Exploration of the fusion mass with confirmed nonunion l2-l3 and l3-l4.2) l5-s1 transforaminal lumbar interbody fusion.3) insertion interbody implant l5-s1.4) laminectomy and decompression l1-l2 and l2-l3 with decompression of l2 and l3 nerve root central, in the foramen, and in the lateral recess.5) (b)(6) osteotomy l1-l2 and l2-l3.6) partial corpectomy via posterior transpedicular approach at l2 including pedicle subtraction of l2.7) t3 to the sacrum and pelvis posterior spinal fusion.8) t3 to the sacrum and pelvis posterior spinal fusion.9) posterior pelvic fixation of the sacrum.10) local autograft 11) morselized allograft 12) interpretation radiographs x8 hours.Implants: 1) titanium screws with cobalt chrome rod.2) carbon fiber interbody implant l5-s1.Per op notes, the fusion mass from t11 down to l3 and l4 were exposed, cleared free of soft tissue and non union was confirmed that l2-l3 and l3-l4.A size 10 carbon fiber interbody cage was placed at l5-s1.The cage and disk space were filled with local autograft and two sheaths of rhbmp-2/acs.The pedicles screws were placed bilaterally from t12 to t3.A right sided pedicle screw was placed at l1 and then bilateral pedicle screws at l3, l4, l5, s1, and the pelvis.During the corpectomy and osteotomy procedures holding rods were maintained in place to maintain the stability across the spine.Maneuvers were then carried out across the holding rods and a left sided rod was cut and contoured laid into place.Radiographs ap and lateral planes confirmed good alignment of the implants and the ap and lateral planes, it was decorticated and local autograft and morsellized 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 and lateral planes showed good alignment of the spine.Patient underwent t3 to pelvis posterior spinal fusion and l2 osteotomy using rhbmp-2/acs bone graft.Four 5x35 screw, four 6x40mm screw, eighteen 6x40mm screw of different model number, and thirty-five 6x40mm screw 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.(b)(6) 2010: patient presented for evaluation of right shoulder pain.Past medical history is significant for severe thoracolumbar kyphoscoliosis.Assessment: 1, right posterior thoracic strain this is superimposed on relatively recent extensive dorsal spine surgery directed at correcting severe kyphoscoliosis.B.There is no clinical evidence to suggest compromise of the spinal fusion.(b)(6) 2010: the patient underwent x-rays of the chest due to cough, shortness of breath and congestion.Impression: 1.Negative for acute pulmonary process.2.Interval correction of scoliosis with posterior fusion hardware.(b)(6) 2011: patient presented with left greater than right lower extremity edema and 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 patient underwent venous duplex ultrasound of bilateral legs due to bilateral lower extremity pain.Opinion: no evidence of deep venous thrombosis in the legs.(b)(6) 2011: patient presented with a history of severe congenital kyphoscoliosis.Assessment: 1) well adult female.A.Depression, exogenous and reactive.2.Chronic thoracolumbar spine disease.A.Status post-surgical correction with an excellent response.B.New left sacroiliac joint pain.3.Status post -surgical menopause with diminished libido; patient would like to address that issue.(b)(6) 2011: the patient underwent x-ray of the chest due to chest pain.Impression: no acute consolidation.(b)(6) 2011: patient presented with posterior thorax demonstrates a midline scar over the dorsal spine, well-healed.Assessment i.Right chest wall pain.A.Query pleurisy.B.Query atypical herpes zoster.(b)(6) 2011: the patient underwent ct angiography of the chest due to right-sided pleuritic chest pain and shortness of breath.Impression:1.) mild scar inferior lingual, no acute appearing infiltrate.3.Mild chronic biliary dilation.(b)(6) 2011: patient presented for follow up.Chest: deformities from longstanding pronounced kyphoscoliosis and surgical correction are stable.She continues to have a considerable right-sided scoliosis.Lungs are clear.There is mild tenderness over the left and right bases.No pleuritic friction rub is audible.Assessment: query suppurative bronchitis versus community acquired pneumonia in a somewhat compromised individual secondary to kyphoscoliosis and surgical treatment there of (restrictive lung disease).(b)(6) 2011: patient 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 and 8th ribs.Assessment: 1.Persistent pleuritic chest pain with suppurative bronchitis.The patient underwent x-ray of the chest due to cough.Impression: no radiographic evidence for acute cardiopulmonary disease.(b)(6) 2011: patient presented with follow up.Assessment: 1.Persistent right chest pain, previously thought to represent pleurisy.A.It seems this is quite possibly a symptomatic manifestation of known cholelithiasis.(b)(6) 2011: patient presented for follow up.Neck veins are flat.Assessment: 1.Recent cholecystectomy.A.Intraoperative cholangiogram, ercp and sphincterotomy day following surgery.(b)(6) 2011: the patient underwent ct of the abscess drainage peritoneal.Opinion: successful ct-guided drainage of a fluid collection in the gallbladder fossa.(b)(6) 2011: the patient underwent "er" biliary ductal system due to bile leak.Impression: leak from gallbladder bed or a leaking duct of luschka.(b)(6) 2011: the patient underwent ct of abdomen due to biloma.Impression: 1.Interval decrease in size of the fluid collection in the gallbladder fossa following drainage catheter placement.2.Residual inflammatory change within the right upper quadrant.3.Bibasilar atelectasis.4.Mild right-sided hydronephrosis of uncertain etiology.(b)(6) 2011: patient presented for follow up.Patient presented with abdominal pain, nausea, vomiting.Assessment: 1.Persistent right upper quadrant pain following cholecystectomy and subsequent bile fluid collection in the right upper quadrant.A.Status post ercp and stenting, b.Status post drainage of right upper quadrant fluid collection.2.Persistent nausea and intermittent fever.A.(b)(6) has now been off antibiotics for about 7 days.B.She appears non-toxic; although she complains of discomfort, she is moving about fairly well in the office.(b)(6) 2011: the patient underwent abdominal ultrasound due to pain and fever.Impression: decreasing size of the complex collection in the gallbladder fossa consistent with resolving biloma or hematoma.(b)(6) 2011: patient presented with follow up.Assessment: 1.Persistent abdominal pain post cholecystectomy and common duct ercp.A.Mild, persistent lipase elevation.(b)(6) 2011: patient presented for follow up.Patient presented with right upper abdominal 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.1.Persistent pain, right upper quadrant, with dyspnea; etiology uncertain.A.Six weeks post laparoscopic cholecystectomy and about 5 weeks post catheter drainage of fluid in the gallbladder bed.B.No current clinical evidence of major infection.(b)(6) 2011: the patient underwent abdominal ultrasound due to probable biloma.Impression: 1.Slight decrease in size of complex collection inferior to the liver consistent with hematoma or biloma.2.Stent within the donor common bile duct.3.New dilation of pancreatic duct.(b)(6) 2011: the patient underwent "ercp" due to right upper quadrant pain.Impression: prior cholecystectomy with normal ercp; mild biliary prominence is present.(b)(6) 2011: the patient underwent ct of the chest due to question biloma.Impression: cholecystectomy.(b)(6) 2011: patient continues to have upper quadrant and 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: 1.Status post recent cholecystectomy with stent placement and successful removal.A.She appears to be recovering well from that illness and the surgical procedures which addressed it.2.Persistent abdominal bloating and pain.3.Right flank pain.4.Previous thoracic spine surgical correction with indwelling hardware.A.Query contributor to the patient's pain syndrome.(b)(6) 2011: patient presented for follow up.Patient has lower chest pain.Neck veins are flat.Carotid upstroke: volume is full and 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 and a half argues against significant thromboembolic phenomenon additionally, she is 3 weeks out from her surgical procedure.(b)(6) 2011: the patient underwent stress echocardiography, which was normal.(b)(6) 2011: patient presented for follow-up.Assessment: 1.Multiple medical problems as above, stable.A.Recovering from complicated cholecystectomy with common duct stenting and extraction of common duct stones.(b)(6) 2011: the patient underwent ct of lumbar spine due to scoliosis surgery and evaluate for bony mass.Impression: 1.Unchanged surgical fusion of the lumbar spine and scoliosis.2.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 and sacral spine is associated with a new l5 laminectomy and there is no evidence of complication.Ct of the thoracic spine was also done.Impression: 1.New posterior hardware fusion and bone graft fusing the posterior elements.2.Mild to moderate diffuse osteopenia; no significant bony encroachment on the thoracic canal or foramina.(b)(6) 2011: the patient presented with follow-up visit.The patient complained of numbness in right arm, headache.Neurologic examination revealed tight hamstrings bilaterally and diminished sensation over the right thigh as well over the medial and lateral aspects of the right foot.Ct scan was reviewed which showed good alignment of the spine and implants.Imaging of the cervical spine showed no cervical stenosis and no evidence of stroke or tumor.Assessment: 1.Residual sagittal imbalance status post l2 pedicle subtraction osteotomy with intermittent fatigue.2.Recent bout with pancreatitis due to complications from cholecystectomy.(b)(6) 2011: patient presented for evaluation of abdominal pain.She describes pain in the right upper quadrant and right lower quadrant and left lower quadrant.Neck: supple.No mass or adenopathy.Assessment: recurrent abdominal pain; this is about 10 weeks post a complicated cholecystectomy.(b)(6) 2011: the patient underwent abdominal ultrasound due to prior cholecystectomy.Impression: 1.Prior cholecystectomy with mildly prominent common bile duct; no intrahepatic biliary dilation to suggest obstruction.(b)(6) 2011: patient presented for follow-up.Neck veins are flat.Carotid upstroke: volume is full and 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 and good entry.Neck veins are flat.Carotid upstroke: volume is full and 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 and good entry.(b)(6) 2011: the patient underwent ct scan of the abdomen and 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.(b)(6) 2011: the patient presented for follow-up and complained of right upper quadrant abdominal and right flank pain.She stated that it was getting worse rather than better.Assessment: persistent right upper quadrant abdominal and right flank pain; etiology uncertain.(b)(6) 2011: the patient presented with abdominal pain.The patient underwent unknown examination.Impression: 1.Long standing history of generalized abdominal discomfort.2.A 7cm low attenuation lesion in the liver, likely a simple cyst.(b)(6) 2011: the patient presented with skin lesion on the right thigh.The patient underwent diuretic renal scintigraphy due to renal obstruction.Impression: 1.Split renal function.2.Right-sided pelvocaliectasis with post lasix parameter in the low indeterminate range for obstruction, no high-grade obstruction in the right kidney.(b)(6) 2011: the patient underwent ct of the abdomen and pelvis due to right sided abdominal pain.Impression: 1.No acute abnormality.2.Prior removal of gall bladder with mild secondary intra and extrahepatic biliary dilation.(b)(6) 2011: the patient 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: 1.Persistent and migrating abdominal pain.2.Retrosternal pain.(b)(6) 2011: the patient presented for an office visit and complained of symptoms suggestive of respiratory tract infection.Assessment: "uri".(b)(6) 2011: the patient underwent x-rays of the chest due to cough.Impression: no radiographic evidence for acute cardiopulmonary disease.(b)(6) 2011: the patient underwent electrocardiography due to chest pain and tachycardia.Summary: 1.Normal biventricular function.2.Normal chamber size.3.Trivial tricuspid regurgitation with normal pulmonary pressures.(b)(6) 2011: the patient complained of shortness of breath, cough and chest pain.Assessment: 1.Post upper respiratory infection, irritation, inflammation or possible allergic reaction to environmental exposure.01/03/2012: the patient presented with chest pain and left upper quadrant abdominal pain.Assessment: 1.Continued chest discomfort with hypoxemia.2.History of severe congenital kyphoscoliosis.The patient underwent lung "nm" due to shortness of breath.Impression: 1.Very low probability of pulmonary embolism.She also underwent chest x-rays.Impression: 1.No radiographic evidence for acute cardiopulmonary disease.(b)(6) 2012: the patient underwent ct of chest due to left lower quadrant abdominal pain.Impression: 1.No acute thoracic or abdominal abnormality.2.Mild right pelvicaliectasis.3.Intra and extrahepatic biliary ductal dilation.4.Indeterminate pulmonary nodules within the right upper lobe measuring up to 6mm in size.(b)(6) 2012: patient presented for follow-up of dyspnea.Impression: 1.Severe combined restrictive and obstructive pulmonary disease in the setting of: a.Kyphoscoliosis status post surgery.B.Possible underlying element of asthma or airway hyper-reactivily.C.No obvious parenchymal lung disease from previous cat scan reports.2.Resting tachycardia with normal echocardiogram.The patient 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.3.History of abdominal pain and discomfort.4.Nonspecific pulmonary nodules, which will need to be followed.(b)(6) 2012: patient presented for follow-up of dyspnea on exertion and pulmonary nodules.The reduced total lung capacity probably is related to her harrington rods.Impression: dyspnea primarily on the basis of uncontrolled asthma.2.Mild elevation of liver functions that will need follow up.3.Small nonspecific pulmonary nodules.I would recommend followup in (b)(6) 2013.4.Mild restrictive pulmonary abnormality secondary to kyphoscoliosis, status post harrington rod placement (b)(6) 2012: the patient presented with chest pain.(b)(6) 2012: the patient presented for follow-up with abdominal pain that was across the upper abdomen in the costal margin.The pain was described as sharp and cramping.Assessment: 1.Restrictive obstructive lung disease.2.Congenital spine deformity.3.Abdominal pain.(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: 1) two years post-operative.2) residual sagittal malalignment 3) poorly controlled asthma.(b)(6) 2012: the patient presented for follow-up with blood pressure check.Assessment: hypoxia; asthma; bronchopneumonia; cp.The patient underwent chest x-rays due to chest pain.Impression: no radiographic evidence for acute cardiopulmonary disease.(b)(6) 2012: the patient presented with dyspnea and chest pain.Electrocardiography was done which revealed normal blood pressure with response to exercise, negative ecg stress test for ischemia.(b)(6) 2012: the patient presented for follow-up with continuous intermittent dyspnea.Assessment: 1.Dyspnea.2.Spine pain currently adequately controlled.(b)(6) 2012: patient presented for follow-up of her asthma.Chest: no wheezes, rales or rhonchi.Breath sounds are slightly diminished.Cardiac: no s3 or s4, extremities show no edema.Impression: 1.Asthma, still not adequately controlled with fev1 of 68% of predicted and asthma control test of 14 2.History of kyphoscoliosis, status post reconstructive surgery.3.Hypoxemia, currently resolved.4.Previous history of right upper quadrant discomfort.Problem resolved.(b)(6) 2012: the patient presented for follow-up 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.(b)(6) 2012: the patient presented for follow-up 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.(b)(6) 2012: patient presented for follow-up.Patient presented with neck pain as well as right leg pain.(b)(6) 2012: patient presented for follow-up of her asthma cough and the ocular and pulmonary symptoms seem to be greatest.Chest: a very faint end-expiratory wheeze can be heard.Cardiac: p2 is not increased.Impression: 1.Asthma with mild exacerbation.2.Restrictive lung disease.3.Kyphoscoliosis.4.History of hypoxemia, which has improved.5.A history of epigastric discomfort, more so now than right upper quadrant pain.(b)(6) 2012: the patient presented for follow-up with persistent right upper quadrant abdominal pain.Assessment: 1.Recurring abdominal pain.A.Query peptic ulcer disease.B.Query proximal structure in the small bowel.C.Query intermittent incomplete small bowel obstruction.(b)(6) 2012: the patient underwent ct of the abdomen and pelvis due to right upper quadrant pain.Opinion: 1.The common bile duct is prominent.2.Fatty atrophy of the pancreas.3.The right renal pelvis is mildly prominent but the calyces are intact.4.Copious stool seen at the right colon consistent with constipation.(b)(6) 2012: the patient presented with pain in stomach and pain in left hip and leg.Assessment: 1.Persistent right upper quadrant/right flank pain.2.Right cva tenderness with pyuria.A.Query insipient pyelonephritis.(b)(6) 2012: the patient presented for follow-up.She continued to have some chest tightness especially anterior with coughing or deep breathing.She had restrictive lungs due to her severe spinal scoliosis.(b)(6) 2012: patient presented for follow-up.Impression: 1) combined obstructive restrictive abnormality from kyphoscoliosis and asthma.2) right upper quadrant pain, probably related to irritable bowel, associated with constipation.3.Recent evaluation in the emergency room showing no evidence of myocardial ischemia or pulmonary emboli as a cause for chest discomfort.4.Suspect elements of esophageal dysmotility and spasm.(b)(6) 2012: patient presented for follow-up.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 and t3 through the sacrum and pelvis posterior spinal fusion.(b)(6) 2012: the patient presented for follow-up with ongoing flank to right lower quadrant abdominal pain with radiation in the inguinal region.Assessment: 1.Persistent right flank pain.2.Chronic constipation.(b)(6) 2012: the patient underwent ct of abdomen and pelvis due to right flank pain and occult hematuria.Impression: 1.Mild prominent of the intra and extrahepatic bile ducts.2.Fatty infiltration of the pancreas.3.Prior cholecystectomy and hysterectomy.4.Moderate right hydronephrosis of uncertain etiology.5.The distal right ureter is not as well opacified as the left.The patient also underwent x-rays of the abdomen due to right flank pain.Impression: 1.Poor opacification of the distal right ureter.2.Moderate right hydronephrosis of uncertain etiology.(b)(6) 2012: the patient underwent mri of the abdomen due to biliary dilation question obstruction.Impression: 1.Stable dilation of common bile duct greater than pancreatic duct; no visible stone; stenosis or a very small obstructing lesion at the annul itself.(b)(6) 2012: the patient presented for follow-up with right upper quadrant abdominal pain, occasional nausea, and 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 and 10th thoracic dermatomes on the right to the mid-posterior thorax.Assessment: 1.Chronic abdominal pain syndrome.2.Back pain.(b)(6) 2012: patient presented for follow-up.Patient presented with some residual back pain.Assesment: 1) two and half years post-operative.2) history of cholecystectomy with postoperative pancreatitis 3) chronic asthma.(b)(6) 2012: the patient presented for follow-up with pain in the right flank and dyspnea.Assessment: 1.Restrictive lung disease.A.This is likely largely secondary to congenital thoracolumbar kyphoscoliosis.2.Chronic back and abdominal pain.3.New skin lesions, right lower extremity.A.Likely focal cellulitic process.(b)(6) 2012: patient presented for follow-up of her asthma and her restrictive lung disease from kyphoscoliosis.She complains of some problems with breathlessness.Her chest exam reveals soft bibasilar crackles.She has diffuse mild abdominal tenderness.Diagnostic impression: 1) 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.2) asthma is certainly not adequately controlled with an fev1 of only 49% of predicted.3) hypoxemia which is primarily "nocturnal" and related to her combined obstructive/ restrictive disease the restrictive component coming for her kyphoscoliosis.The patient underwent x ray of the chest region.Impression: 1.No radiographic evidence of pneumonia.2.Dual posterior fixation rods, thoracic and lumbar spine.(b)(6) 2012: the patient underwent routine c-echo test.Impression: 1.Left ventricular systolic function is hyperdynamic.2.Borderline rv systolic dysfunction.3.Right ventricular systolic pressure is normal.(b)(6) 2012: the patient presented for follow-up.Assessment: 1.Recent episode of altered consciousness, as above; etiology uncertain.A.History of severe thoracolumbar scoliosis status post-surgical repair.B.History of severe restrictive lung disease and associated hypoxemia.C.Questionable history of reactive airways disease.(b)(6) 2012: the patient underwent ct of head due to blurred vision.Impression: 1.No intracranial abnormality.2.No stroke, space- occupying lesion seen.(b)(6) 2012: the patient presented with excessive sleep.(b)(6) 2012: patient presented for follow-up.Assesment: 1) two and one half years post-operative.2) chronic asthma.Echocardiogram indicates hyperdynamic left ventricular function, borderline rv dysfunction and normal right systolic pressure.(b)(6) 2012: the patient presented with recurrent right upper quadrant abdominal pain.Ct scan of the head was reviewed which was negative for any evidence of intracranial injury or bleed.Assessment: 1.Recurrent right upper quadrant abdominal pain, etiology uncertain.2.Congenital spine disease.3.Chronic depression.4.Restrictive lung disease.(b)(6) 2012: the patient presented for follow-up with varying blood pressure.She was symptomatic in both extremes with headaches, nausea, sweating, dyspnea, and lightheadedness.Assessment: 1.Multifactorial compromise of respiratory function.A.Restrictive lung disease.B.Reactive airways disease.C.Chronic mild hypoxia.D.Query sleep apnea syndrome.(b)(6) 2013: patient presented for follow-up.Assesment: 1)3+ years post-operative.2) residual sagittal malalignment.3) chronic asthma.4) recent chest pain with abnormal ekg.(b)(6) 2013: the patient presented with chest pain and fluctuations in blood pressure.She also had complaints of dyspnea, nausea.Neck was supple.Chest was moderate dextroscoliosis.(b)(6) 2013: the patient presented with right arm pain.She developed pain and swelling at the site of the phlebotomy with proximal pain stranding up the medial aspect of the right biceps.Assessment: right arm cellulitis.A.Query brachiocephalic vein thrombophlebitis.(b)(6) 2013: the patient presented with shortness of breath.Assessment: dyspnea.The patient underwent x-rays of the chest due to shortness of breath.Impression: no radiographic evidence for acute cardiopulmonary disease.(b)(6) 2013: patient presented for follow up.Patient presented with the complaint for increasing breathlessness and cardiac etiology.The x-ray showed no acute diseases.The patient 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 and chest wall and if she coughs or sneezes.Impression:1) combined obstructive/restrictive abnormality.The restriction is on the basis of her kyphoscoliosis and the obstruction on the basis of asthma.2) query nocturnal hypoxemia.This needs additional reevaluation.3) history of palpitations.Suspect the patient may be having supraventricular tachycardia versus atrial flutter or atrial fibrillation.This needs more evaluation with a holter monitor.4) severe dyspnea on exertion, which seems disproportionate to her findings, especially since pulmonary function and 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.(b)(6) 2013: patient presented with dizziness, short of breath, chest tightness, chest pain.(b)(6) 2013: the patient presented with right leg pain.She had pain and 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: 1.Right leg pain, unknown etiology.2.History of chronic lung disease.The patient underwent ultrasound venous duplex of right leg due to redness and swelling.Impression: normal venous doppler ultrasound with no findings of dvt.(b)(6) 2013: patient presented for follow-up.Patient presented with severe pain from neck down to her tailbone, has residual sagittal malalignment as per pelvic parameters.Patient underwent x-ray which reveals that ap/lateral scoliosis views demonstrate intact implants.Continues to have sagittal malalignment.Assesment: 1)3+ years post-operative.2) residual sagittal malalignment.3) chronic asthma.4) chronic pain.(b)(6) 2013: patient underwent x-rays of the chest due to chest pain.Impression: mildly low lung volumes.(b)(6) 2013: patient presented for follow-up.Patient presented with back pain, facial numbness, 60 ht sided upper and lower extremity weakness and numbness and having likely a tia.Patient underwent ct scan of the thoracic and lumbar spine which shows solid arthrodesis from t3 through s1.Shows pso at l2.Assesment: residual sagittal malalignment.(b)(6) 2013: patient underwent ct scan of the thoracic and lumbar spine.Impression: thoraco-lumbar posterior and lumbar anterior surgical fusion unchanged from comparison on (b)(6) 2011.Degenerative findings are also stable in the presence of mild to moderate osteopenia.(b)(6) 2013: the patient presented for follow-up.Assessment: 1.Recent cryptogenic thalamic tia.A.Stable at this point.(b)(6) 2013: the patient presented for follow-up.Assessment: 1.Recent cryptogenic thalamic tia.A.Persistent l lateral rectus m.Palsy.(b)(6) 2013: patient underwent mri and ct scan of the head and neck region.(b)(6) 2013: the patient presented for follow-up.Assessment: 1.Recent episode of facial palsy and cross-over major motor deficit, recovered.2.Query highly atypical migraine syndrome.3.Intolerance to topiramate.(b)(6) 2013: the patient presented with blood in stool.Assessment: 1.Query atypical migraine.2.Hemorrhoids, internal and external.(b)(6) 2013: the patient presented with pleuritic chest pain on the left at the site of impact in the lower anterior left chest wall.Assessment: 1.Chest wall contusion.2.Query secondary bronchitis.(b)(6) 2013: patient presented for follow-up.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.(b)(6) 2013: the patient presented with hurting in right side.She also complained of back pain and headache.Neurologic examination dizziness, lightheadedness, facial weakness, speech difficulties.(b)(6) 2014: the patient presented with spots/rash on arms and 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 Key5027662
MDR Text Key23988089
Report Number1030489-2015-02078
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
Date FDA Received08/25/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/01/2011
Device Catalogue Number7510600
Device Lot NumberM110809AAG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/27/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/05/2009
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) Other;
Patient Weight70
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