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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 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Chest Pain (1776); Contusion (1787); Dyspnea (1816); Edema (1820); Fatigue (1849); Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Vomiting (2144); Weakness (2145); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Stenosis (2263); Injury (2348); Depression (2361); Disability (2371); Sore Throat (2396); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Shaking/Tremors (2515); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Weight Changes (2607)
Event Type  Injury  
Event Description
It was reported that the patient underwent a plif at l5-s1 using saber fusion cages and rhbmp-2/acs.It was reported that following the surgery the patient did not improve and developed worse pain, symptoms, and disability.Specifically, it was reported that the patient experienced pain in his back and legs.
 
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).
 
Event Description
Reportedly,the patient had pain in back and hips, radiating down his legs.His feet hurt as well and he had burning sensation in lower extremities.These conditions led to rhbmp-2/acs surgery.From 2001 to 2012, the patient visited the chiropractor.On an unknown date in 2001, the patient presented with diagnosis of chronic back pain.On unknown dates from 2004-2006, the patient presented with diagnosis of chronic back pain.From 2004 to 2007, the patient presented with diagnosis of chronic back pain.On an unknown date in 2006, the patient presented with diagnosis of chronic back pain.On (b)(6) 2006, the patient presented due to confusion caused by pain medication.On (b)(6) 2006, the patient presented for an office visit.On an unknown date in 2007, the patient presented with diagnosis of back pain.On an unknown date in 2008, the patient presented for second opinion for back pain.From 2011 to present day, the patient presented with diagnosis of cervical, lumbar pain.From 2012 to present day, the patient presented with diagnosis of depression and anxiety.On an unknown date in 2014, the patient presented due to heart catheterization.Post-op, the patient presented with chronic back pain, tenderness in back, limited mobility and difficulty bending over.Currently, the patient is experiencing chronic back pain, tenderness in back, limited mobility and difficulty bending over.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on, (b)(6) 2001 the patient complained of low back pain.(b)(6) 2004 the patient presented with exacerbated pain, muscle spasm, positive straight leg raise test bilaterally, depressed left ankle reflex.He has had problems with urinary frequency.(b)(6) 2004 the patient presented with periodic back and leg pain.Mild tenderness was present at l5.Mild guarding was present.(b)(6) 2004 the patient presented with burning sensation in his feet.The patient underwent the following exam: spasm and tenderness over the posterior paralumbar region.Impression: posttraumatic lumbar strain and spasm.Chronic pain syndrome, lumbar spondylosis, lumbar radiculopathy, dysesthesias.(b)(6) 2004: the patient underwent cath.(b)(6) 2005 the patient presented with the following indications: low back pain, pain down the legs, dysesthesias in the feet.Nerve conduction studies and electromyography were performed.Impression: 1.This study shows evidence for early active denervation bilaterally in a l5 and s1 nerve root distribution.L4 involvement is identified, however to a lesser extent.Bilateral lumbar radiculopathy is suspected.2.In addition, there is evidence for a mild sensory and motor peripheral polyneuropathy affecting axonal and myelin components.(b)(6) 2005 the patient presented for consultation.(b)(6) 2005: patient presented with back and leg pain.(b)(6) 2006 the patient presented with continued low back pain down the left leg, neck pain , muscle spasm and tenderness over the posterior paralumbar and paracervical region.Impression: lumbar spondylolisthesis, lumbar radiculopathy.(b)(6) 2006 the patient presented for a follow up.(b)(6) 2006 the patient presented for a follow up visit.(b)(6) 2007 the patient presented with forward head rounded shoulders posture and increased lumbar lordosis especially at the l3-l4 vertebral level.Problems: 1.Pain.2.Decreased strength.3.Flexibility and range of motion.(b)(6) 2007 the patient presented for a follow up.He complained of severe low back pain, hip pain and pain in the left leg.He reported weakness in the left leg.Impression: 1.Chronic pain syndrome.2.Chronic mechanical low back pain.3.Ruled out failed back syndrome.4.Dysesthesias.(b)(6) 2007 the patient presented for re-evaluation.(b)(6) 2007 the patient underwent the following procedures: nerve conduction studies and electromyography.Impression: abnormal study.(b)(6) 2007 the patient presented to the office for a follow up.
 
Event Description
It was reported that on, (b)(6) 2004 the patient presented with exacerbated pain in lower back and both legs, muscle spasm, positive straight leg raise test bilaterally, depressed left ankle reflex.He has had problems with urinary frequency.Impression: 1.Bilateral lumbar spondylosis with spondylolisthesis, rule out instability.2.Lumbar radiculopathy.(b)(6) 2004 the patient presented with burning sensation in his feet.He continues to have low back pain, pain down his legs.(b)(6) 2005, : the patient presented with neck upper mid and lower back pain, left thigh and hand is numb, numbness, tingling, dysesthesias, and paresthesias in his feet.(b)(6) 2005: patient presented with low back pain, pain down the legs.Impression: mechanical low back pain, lumbar radiculopathy, rules out peripheral polyneuropathy, spondylosis, lumbar spondylolisthesis.He also complains of some sexual dysfunction and difficulty maintaining an erection.Impression: 1.Mechanical neck and low back pain.2.Lumbar radiculopathy.3.Lumbar spondylolisthesis, l5-s1.4.Sexual impairment.5.Peripheral polyneuropathy.(b)(6) 2006: the patient was admitted to the hospital with diagnosis of l5-s1 lumbar laminectomy for gill fragment discectomy and complaints of back pain and urinary hesitancy and frequency, pain and paraesthesias in his feet, thigh and groin area.The patient underwent a surgery with diagnosis of lumbar spondylolisthesis and lumbar spondylolysis with radiculopathy.Patient underwent following procedures: 1.Bilateral l5 laminectomy for gill fragment removal.2.Bilateral posterior lumbar interbody fusion using saber cages with rhbmp.3.Aborted pedicle fixation.4.Intraoperative monitoring -ssep uppers and emg lowers.Per op-notes, once the sac was decompressed and the disc removed, which was degenerative in nature, the disc space was quite narrow.Trials were attempted.The largest size that could be used for trial cage was a 9mm width and a 9mm height.Attempts to place an 11 mm height was unsuccessful.A medium bmp kit system was used with the sponges soaked for 20 minutes.These were than packed, 1.5 sponges per sager cage.Trial also showed that a 22 mm cage was the ideal size making for 9x9x22 mm bilateral cages.Cages were then selected and packed with bmp.Wound was then closed in multiple anatomic layers of vicryl including 4-0 subcuticular closure.Steri-strips were applied.On (b)(6) 2006, the patient underwent lumbar spine xray due to lumbar laminectomy.The xray showed spondylosis at l5-s1.Inter disc device at l5-s1.Probable gown clip overlies the disc space on the lateral view at l1-2 not seen on the ap view.
 
Event Description
It was reported that on (b)(6) 2014 patient presented due to memory problem and chronic pain.On (b)(6) 2014 patient presented due to pain, frustration and depression.On (b)(6) 2014 patient presented due to depression and pain.On (b)(6) 2015: patient presented due to depression.On (b)(6) 2015: patient presented due to depression and his medical status was with low energy and sleepy.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 1992: patient presented with acute exacerbation, pain and stiffness in the low back, muscle spasms, edema.On (b)(6) 1992: patient presented with injured neck and low back and right anterior abdomen while lifting a tarp.On (b)(6) 1992: patient presented with acute cervical pain, acute lumbosacral sprain, spondylolisthesis.On (b)(6) 1992: patient presented with acute exacerbation, pain and stiffness in the low back, muscle spasms, numbness and tingling.On (b)(6) 1992: patient presented with pain and stiffness and low back pain and neck pain.On (b)(6) 1992: patient presented with pain and stiffness in neck, low back, dorsolumbar spasm moderate l4/l5 tender to palpation.On (b)(6) 1992, (b)(6) 1993, (b)(6) 1994: patient presented with acute exacerbation, increased pain and stiffness in shoulders pointed to both upper traps.On (b)(6) 1992, (b)(6) 1993, (b)(6) 1994: patient presented with complaint of slight pain in the neck, numbness at night in both the hands.On (b)(6) 1992: patient presented with numbness in hands, right and middle finger.On (b)(6) 1993: patient presented with neck pain and numbness radiating down to arm, acute cervical sprain, acute ,lumbosacral strain.On (b)(6) 1995: patient presented with contusion of thigh.On (b)(6) 1995: the patient presented with pain in his lower back, pain in both of his legs.On (b)(6) 1996: patient presented with pain and stiffness in low back and neck.Point tenderness l4-5 and both psis.On (b)(6) 1996: patient presented with pain and stiffness in mild back, point tenderness c5/c6/c7.On (b)(6)1999: the patient presented with sprain in lumbar region.Hurt lower back on (b)(6) 1999: patient presented with low back pain.The patient underwent x-ray of lumbar spine.Impression: there are moderate hypertropic degenerative changes of the lower thoracic spine and also intervertebral disc spaces at l1-2 and l4-5.On (b)(6) 2001: the patient was diagnosed for cervical strain, lumbar sprain.The patient presented with an injury.On (b)(6) 2001: patient underwent x-ray of the lumbar spine which revealed mild degenerative disc disease of the lumbar spine and bilateral spondylolysis and grade 1 spondylolisthesis of l5 on s1.Cervical x-ray revealed mild degenerative disc disease at c4-c6.On (b)(6) 2001: the patient presented with pain and stiffness due to dorsolumbar spasm still mild t10-s1.Point tenderness.On (b)(6) 2001: the patient presented with increased pain and stiffness in low back and neck.Mild spasm, point tenderness lumbar fusion, psis, both upper traps, point tenderness c5/6.On (b)(6) 2002: the patient presented with pain and stiffness, side of neck, bilateral low back pain,short leg, dorsolumbar spasm mod.T10-s1 bilaterally, with point tenderness c5-6, moderate myofascial trigger points throughout medial and superior border of left scapula.On (b)(6) 2003: the patient underwent an mri which revealed bilateral l5 spondylolysis with grade 1 spondylisthesis of l5 on s1, disc bulging from t12- l5.On (b)(6) 2003, (b)(6) 2004: patient presented with lower back pain.6 feb 2004: the patient presented with the following impressions: chronic pain syndrome.Lumbar spondylolisthesis.Lumbar radiculopathy.On (b)(6) 2004,: the patient presented with low back pain, right arm and right heel pain.On (b)(6) 2005: the patient presented with neck upper mid and lower back pain, left thigh and hand is numb.On (b)(6) 2005,: patient presented with low back pain, pain down the legs.Impression: mechanical low back pain, lumbar radiculopathy, rule out peripheral polyneuropathy, spondylosis, lumbar spondylolisthesis.On (b)(6) 2006, (b)(6) 2005: patient presented with neck, upper back pain, numbness in both hands, pain in lower arms.On (b)(6) 2007, (b)(6) 2006: patient presented with both hands numb, neck pain.On (b)(6) 2007, (b)(6) 2006, :patient presented with neck upper mid, lower back pain, numbness in hands and shoulder.On (b)(6) 2007: patient presented with neck upper mid, lower back pain, pain in shoulder.On (b)(6) 2007: patient presented with back pain, pain off to the left hip and down the left leg.Impression: chronic back syndrome.Mechanical low back pain.Failed back syndrome.Left lumbar radiculopathy.Chronic insomnia, sleep disturbance.On (b)(6) 2007: patient presented with back pain and pain primarily down the left leg.Impression: chronic pain syndrome.Chronic mechanical low back pain.Left lumbar radiculopathy.On (b)(6) 2009,(b)(6) 2007, (b)(6) 2006, (b)(6) 2005: patient presented with neck upper mid, lower back pain, pain in legs, feet, numbness in hands, legs and feet.On (b)(6) 2010, (b)(6) 2012: patient presented with low back pain and leg pain.On (b)(6) 2010, (b)(6) 2011, (b)(6) 2012: patient presented with low back pain.On (b)(6) 2011, (b)(6) 2012: patient presented with hip pain, leg pain, back pain.On (b)(6) 2011, (b)(6) 2006: patient presented with low back pain and neck pain.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2006 the patient presented for an office visit.On (b)(6) 2006 the patient presented for myoview stress test and ecg.On (b)(6) 2006 the patient was admitted for st myoview/ echo.Impression : normal right and left ventricular size contractility.Mild left atrial enlargement.Mild mitral and tricuspid regurgitation.Impression(myocardial perfusion): no evidence of ischemia or old my ocardial infarction.Ejection fraction was 62%.On (b)(6) 2006 the patient underwent chest pa lateral due to spondylolisthesis.Impression: no active pulmonary disease.On (b)(6) 2006 the patient was admitted after being in a motor vehicle accident.He complained of c/o neck and back pain.The patient got x-ray done for c-spine and l-spine region.The patient was diagnosed with neck and back strain.Impression: cervical: there is normal alignment of the cervical spine.Vertebral body heights and disc spaces are maintained.No acute fracture or subluxation.The neural foramina and odontoid are unremarkable.Lumbar: there is bilateral spondylolysis at the l5 level with grade 1 spondylolisthesis.Vertebral body heights and disc spaces are maintained.No acute fracture or subluxation.On (b)(6) 2006 the patient underwent x-ray examination of the lumbar spine due to lumbar fusion.Impression: post-surgical changes were seen at l5-s1 disk.The alignment suggested a mild 8mm anterolisthesis of l5 relative to s1.On (b)(6) 2006 the patient underwent x-ray examination of the lumbar spine due to lumbar neuritis.Comparison with the x-ray exam in (b)(6) 2006.Impression: post-surgical changes l5-s1 with disc strut and also resection of the inferior posterior vertebral body of l5 was present.There was an anterolisthesis of l5 on to s1 unchanged since prior examination measured at 10mm.Post-surgical changes of laminectomy were also present.On (b)(6) 2006 the patient took an x-ray examination of the lumbar spine due to back pain.Impression: multilevel disc disease was present with disc narrowing and osteophyte formation was present throughout most prominent upper lumbar and lower thoracic vertebral bodies.There was some slight wedging of the lower thoracic and upper lumbar vertebral bodies.This was suspected chronic in nature by the doctor.No acute compression fracture was identified.Post-surgical changes were present l5-s1.Mild anterolisthesis of l5 on s1 of approximately 5mm was present.On (b)(6) 2007 the patient presented for an x-ray of lumbar spine due to back pain.Impression: post-surgical changes l5/s1.Mild degenerative changes were found.On (b)(6) 2008 the patient was admitted as he complained of talking out of head and shaking.The patient underwent ct of brain/head.Impression: no ct evidence of acute intracranial abnormality.On (b)(6) 2008 the patient presented for an office visit.On an unspecified date in (b)(6) 2006, patient underwent l5-s1 fusion.On (b)(6) 2010: patient presented with low back pain, neck pain, leg and feet pain, numbness in hand, feet, legs, arms (b)(6) 2009: patient underwent mri of the cervical spine.Impression: mild multilevel degenerative disc disease.On (b)(6) 2009: patient presented for an office visit.Impression: neck and lower back pain radiating to upper extremities.On (b)(6) 2009, (b)(6) 2010: patient presented for follow-up.Impression: failed lower back surgery syndrome; chronic radiculopathy; lower back pain; cervicalgia.(b)(6) 2010: patient presented with lumbago, cervicalgia, radiculopathy.On (b)(6) 2010: patient presented with bwc, degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: lumbar pain, parvertebral contracture lumbar bil with restricted motion.Paravertebral contracture cervical with decreased forward flexion and sidebending and rotation.On (b)(6) 2010, (b)(6) 2011: patient presented for an office visit.Patient presented with back, neck pain, degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.On (b)(6) 2011: patient presented for an office visit.Patient presented with back which goes into the left leg posterior upper thigh.D egeneration of cervical inter, degeneration of lumbar, spondylolisthesis.(b)(6) 2011 (b)(6) 2012: patient presented for an office visit.Patient presented with cervical pain, lumbar pain, degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.On (b)(6) 2011: patient presented for an office visit.Patient presented with cervical pain, lumbar pain, lumbar worse burning sensation left buttock into leg, degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.On (b)(6) 2011: patient presented for an office visit.Patient presented with cervical pain, lumbar pain, cervical tightness continues, back upper thorax contracted decreased side bending and rotation bil, limbar went to sit down and spasmed left lumbar sought treatment at chiropractor with some relief, degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.On (b)(6) 2011: patient presented for an office visit.Patient presented with cervical pain, lumbar pain, degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: restricted rom with forward motion with pain, parvertebral contracture thorax with decreased side bending and rotation bil.On (b)(6) 2011: patient presented for an office visit.Patient presented with cervical pain, lumbar pain, degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: restricted rom with forward motion with pain paravertevral contracture thorax with decreased side bending and rotation bil.Cervical rom flexion 34 ext 22 right sidebending 29 left sidebending 32 lumbar rom flexion 39 ext 21 right sidebending 26 left sidebending 16.On (b)(6) 2012: patient presented for an office visit.Patient presented with back which goes into the left leg posterior upper thigh, d egeneration of cervical inter, degeneration of lumbar, spondylolisthesis, cervical some pain not that bad, lumbar at time worse than usual with radiation into his left and thigh but not down his leg like it was before.On (b)(6) 2012: patient presented for an office visit.Patient presented with cervical pain, lumbar pain, degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: restricted rom with forward motion with pain paravertevral contracture thorax with decreased side bending and rotation bil.On (b)(6) 2012: patient presented for an office visit.Patient presented with back, cervical same stable lumbar painful at time with forward bending last several day which goes into the left leg posterior upper thigh.Degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: restricted rom with forward motion with pain paravertevral contracture thorax with decreased side bending and rotation bil.On (b)(6) 2013: p atient presented for an office visit.Patient presented with back, cervical degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: restricted rom with forward motion with pain paravertevral contracture thorax with decreased side bending and rotation bil.On (b)(6) 2013, (b)(6) 2014: patient presented for an office visit.Patient presented with back, cervical degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musc uloskeletal: restricted rom with forward motion with pain paravertevral contracture thorax with decreased side bending and rotation bil.Slow to preform rom lumbar and getting up from seated position.On (b)(6) 2014: patient presented with back pain.Patient underwent ct scan of the lumbar spine without contrast.Impression: chronic pars fracture of ls.With associated grade 1 anterolisthesis.Irregular disc osteophytic ridging and posttreatment related changes at ls-s more prominent on the right side probably some mass effect the right side of the thecal sac and right lateral recess.Severe neural frontal stenosis at ls-s1.On (b)(6) 2014: patient presented for an office visit.Patient presented with back, cervical degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: restricted rom with forward motion with pain paravertevral contracture thorax with decreased side bending and rotation bil.Slow to preform rom lumbar and getting up from seated position.Patient underwent ct scan of lumbar region which shows presence of mass.On (b)(6) 2014: patient presented for an office visit.Patient presented with back, cervical degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: restricted rom with forward motion with pain paravertevral contracture thorax with decreased side bending and rotation bil.On (b)(6) 2014: patient presented for an office visit.Patient presented with back, analgesia, cervical degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: range of motion lumbar flexion 30 extension for side many right 16 sides bending left eight.On (b)(6) 2014: patient presented for an office visit.Patient presented with back, analgesia, cervical degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: range of motion lumbar flexion 16 extension five side bending right six side bending left eight.On (b)(6) 2014: patient presented for an office visit.Patient presented with back, analgesia, cervical degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: range of motion lumbar flexion 36 extension two side bending right ten side bending left eight.On (b)(6) 2014: patient presented for an office visit.Patient presented with back, analgesia, cervical degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: range of motion lumbar flexion 25 extension seven side bending right ten side bending left ten.On (b)(6) 2015: patient presented for an office visit.Patient presented with back, analgesia, cervical degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: range of motion lumbar flexion 30 extension eight side bending right nine side bending left nine.On (b)(6) 2015: patient presented for an office visit.Patient presented with back, analgesia, cervical degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: range of motion lumbar flexion 42 extension 3 side bending right 15 side bending left 13.On (b)(6) 2015: patient presented for an office visit.Patient presented with back, analgesia, cervical degeneration of cervical inter, degeneration of lumbar, spondylolisthesis.Musculoskeletal: range of motion lumbar flexion 35 extension 4 side bending right 11 side bending left 11.On (b)(6) 2014: patient presented for an office visit.Patient presented with degeneration of cervical inter, degeneration of lumbar, sp ondylolisthesis.Musculoskeletal: range of motion lumbar flexion 16 extension 5 side bending right 6 side bending left 8.On (b)(6) 2006 the patient underwent other tests as well including ¿echo tte complt w/o spect/dopl, echo dplr complt¿ and stress test.On (b)(6) 2006: the patient was admitted to the hospital.On (b)(6) 2006: the patient was discharged home.On (b)(6) 2006: the patient was admitted to the hospital.On (b)(6) 2006: the patient was admitted to the hospital.On (b)(6) 2006: the patient was admitted to the hospital.On (b)(6) 2006: the patient was admitted to the hospital.On (b)(6) 2006: the patient was admitted to the hospital.On (b)(6) 2006: the patient was admitted to the hospital.On (b)(6) 2007: the patient was admitted to the hospital.On (b)(6) 2007: the patient was discharged home.On (b)(6) 2008, per the billing records, the patient underwent x-rays of the chest and ct scan of the head/brain without contrast.On (b)(6) 2006: the patient was admitted to the hospital with diagnosis of l5-s1 lumbar laminectomy for gill fragment discectomy and complaints of back pain and urinary hesitancy and frequency, pain and paraesthesis in his feet, thigh and groin area.The patient underwent a surgery with diagnosis of lumbar spondylolisthesis and lumbar spondylolysis with radiculopathy.Per op-notes, once the sac was decompressed and the disc removed, which was degenerative in nature, the disc space was quite narrow.Trials were attempted.The largest size that could be used for trial cage was a 9mm width and a 9mm height.Attempts to place an 11 mm height was unsuccessful.A medium bmp kit system was used with the sponges soaked for 20 minutes.These were than packed, 1.5 sponges per sager cage.Trial also showed that a 22 mm cage was the ideal size making for 9x9x22 mm bilateral cages.Cages were then selected and packed with bmp.Wound was then closed in multiple anatomic layers of vicryl including 4-0 subcuticular closure.Steri-strips were applied.On (b)(6) 2006, the patient underwent lumbar spine x-ray due to lumbar laminectomy.The xray showed spondylosis at l5-s1.Inter disc device at l5-s1.Probable gown clip overlies the disc space on the lateral view at l1-2 not seen on the ap view.On (b)(6) 2004: the patient presented for consultation.On (b)(6) 2004: the patient underwent cath.On (b)(6) 2010: the patient presented for severe heart burn extending into chest pain.On (b)(6) 10: the patient presented with abdominal pain, bloating, chest pain.The patient underwent stress myoview scan with gated study.Normal (b)(6) 2014: the patient presented with chest pain.The patient underwent stress test.On (b)(6) 2014: the patient underwent left heart cath, coronary angiography, left ventriculography.Normal (b)(6) 2003: patient presented for follow up bug bite.Assessment: spider bite.On (b)(6) 2003: patient presented for follow up bug bite, lower extremity edema and check up on blood pressure.Patient complained of chronic situation and stated that when he was on his feet all day, he had noticed that at the end of the day that his lower legs were swollen.Assessment: spider bite, improved; lower extremity edema; hypercholesterolemia.On (b)(6) 2003: patient presented for follow up of cholesterol as well as bite on his neck and sexual promiscuity.Assessment: impetigo of insect bite; insomnia; high risk sexual behavior.On (b)(6) 2004: patient presented with chest pain that radiated to his back and shoulder.Assessment: chest pain; hyperglycemia; elevated bun and creatinine.Patient underwent chest x-ray due to shortness of breath and chest pain.Impression: the left pleural cavity air fluid level is absent and there is pleural thickening; lateral decubitus view of the chest is recommended.X-ray also showed following: mild cardimegaly with mild pulmonary venous hypertension; increased markings at the right lung base may be indicative of an early infiltrate.On (b)(6) 2004: patient presented for consultation with chest discomfort radiating to the left shoulder.Impression: middle aged male with acute renal insufficiency on admission that may have been secondary to nonsteroidal anti-inflammatory drug therapy.On (b)(6) 2004: patient was discharged with following discharge diagnosis: atypical chest pain; mild cardiomyopathy; question of renal insufficiency; glucose intolerance.(b)(6) 2004: patient underwent gall bladder ultrasound due to chest pain.Impression: normal gall bladder ultrasound.Patient underwent upper gi x-ray due to upper abdominal pain.Impression: normal upper gi study.On (b)(6) 2004: patient presented with diarrhea, off and on for several years.Assessment: irritable bowel disease; hypertension; anxiety <(>&<)> depression.On (b)(6) 2005: patient presented with neck and back pain which was work injury.On (b)(6) 2005: patient underwent mri of lumbar spine.Impression: possible spondylosis with less than grade i spondylolisthesis at the l5-s1 level; very mild right paracentral l4-l5 herniated-protruded disc with very minimal asymmetric compression on the thecal sac on the right side; degenerative disc changes.Patient underwent lumbar spine x-ray due to low back pain.Impression: moderate spondylolisthesis at l5 over s1 measuring 7 mm on flexion views and 8 mm on extension view.3 mm posterior spondylolisthesis of l1 over l2.This finding is stable in both flexion and extension views.Patient underwent orbits x-ray due to foreign body to eye.Impression: ap and lateral views of orbits demonstrate no evidence for metallic foreign bodies.On (b)(6) 2005: patient presented with dynamic instability at l5/s1, consistent with his spondylolisthesis with spondylolysis and pars defect, pre-existing condition aggravated by work injury.On (b)(6) 2005: patient presented with back pain, numbness in feet, mild urinary frequency and diarrhea.Patient had swelling of abdominal wall.Diagnoses: abdominal wall abscess; hyperglycemia.On (b)(6) 2005: patient presented with swelling in feet.Diagnoses: htn, edema feet.On (b)(6) 2005: patient presented with back and leg pain.On (b)(6) 2006: patient presented for pre-op clearance.Diagnosis: back pain.On (b)(6) 2006: patient presented for follow up of pain.Mri revealed transverse process spondylolisthesis, spondylolysis, degenerative disc disease, mild at l4/5.On (b)(6) 2006: patient presented with chest discomfort.Diagnoses: chest pain, back pain, depression, fatigue.On (b)(6)2006:patient underwent following procedures: bilateral l5 laminectomy for gill fragment removal; bilateral posterior lumbar interbody fusion using saber cages with rhbmp; aborted pedicle fixation; intraoperative monitoring ¿ ssep uppers and emg lowers.On (b)(6) 2006: patient presented with sore throat, fever, cough, minimal expectoration and nausea, chronic back pain.Diagnoses: back pain, urti, depression.On (b)(6) 2006: patient presented with residual numbness in the ball of his foot and in between his toes which continued to improve.There was improvement in leg pain as well.On (b)(6) 2006: patient presented with back pain.Diagnoses: uti, back pain, depression, chronic insomnia.On (b)(6) 2006: patient presented for diagnostic assessment stating that patient could not sleep and was depressed.Diagnostic impression: axis i: dysthymic disorder, late onset.Axis ii: deferred.Axis iii: orthopedic surgery in the form of fusion.Axis iv: unemployment secondary to orthopedic injury.Financial problems.Disorder with workers compensation.Transition to disablement and change of life style.Axis v: gaf: 52.On (b)(6) 2006: patient was admitted with swelling and right foot pain.Impression: cellulitis of his right foot.On (b)(6) 2006: patient presented with swelling and right foot pain.Impression: cellulitis, right foot.Possible staph infection.; de pression <(>&<)> anxiety; status post spinal surgery with vertebral fusion.On (b)(6) 2006: patient presented for psychiatric evaluation reported having difficulty sleeping.Diagnostic impression: axis 1 mood d isorder, secondary to back injury with depressive features.Adjustment disorder, dysthymic disorder.Axis 2: no diagnosis.Axis 3: chronic back pain status post spinal fusion.Axis 4: financial problems.Occupational problems.Limited primary support.Axis 5: current gaf: approximately 60.Patient was discharged with following diagnoses: cellulitis, right foot; depression; obesity; arthritis.On (b)(6) 2006: patient complained of cellulitis right leg.Diagnoses: cellulitis right leg; back pain.On (b)(6) 2006: patient presented for evaluation of dysthymia with anxiety and for medication assessment.On (b)(6) 2006: patient presented for lt si injection under c-arm.On (b)(6) 2006: patient underwent wechsler adult intelligence scale ¿ iii and nelson-denny reading test.Diagnostic impression ¿ axis i: dysthymic disorder; somatoform disorder not otherwise specified.Axis ii: borderline intelligence.Axis iii: c/o overweight; back problems; leg and feet difficulties; neck pain; numbness in extremities; s/p back surgery.Axis iv: psychosocial stressors.Axis v: current gaf: 55 to 59.On (b)(6) 2007: patient underwent mammo diagnostic bilateral due to left breast mass.Impression: no mammographic evidence of breast tissue or malignancy on the right; mild left gynecomastia.No mammographic evidence of malignancy.Bi-rads: 0.Patient also underwent us breast left unilateral or bilateral.Impression: asymmetric gynecomastia.No sonographic or mammographic evidence of malignancy; some breast cancer, even when palpable, not detected by mammography.Bi-rads classification: 2.(b)(6) 2008: patient underwent non-contrast head ct.Impression: no ct evidence of acute intracranial abnormality.On (b)(6) 2008: patient presented with pain and depression.Diagnoses: axis i: depression nos.Axis ii: diagnosis deferred.Axis iii: allowed industrial condition, obesity, and hypertension.Axis iv: health issues.Axis v: gaf current 60.On (b)(6) 2009: patient underwent mri head without contrast due to history of head pressure with blurred vision.Impression: a few areas of white matter signal abnormality which could relate to migraine headaches, demyelination, chronic microvascular ischemic changes as well as many other etiologies.On (b)(6) 2009: patient presented for follow up of probably benign gynecomastia in the left breast and underwent mammo diagnostic bilateral study.Impression: right breast ¿ normal.Acr bi-rads category 1; left breast ¿ benign gynecomastia.Acr bi-rads category 0.On (b)(6) 2009: patient underwent nerve conduction velocity study.Impression: normal study.There is no evidence of neuropathy seen.On (b)(6) 2009: patient underwent nerve conduction velocity study and electromyography study.Impression: abnormal study.There is subtle evidence of a bilateral chronic radiculopathy that is difficult to localize further.On (b)(6) 2009: patient underwent mri cervical spine without contrast due to neck pain.Impression: mild multilevel degenerative disc disease.On (b)(6) 2010: patient underwent chest x-ray due to chest pain.Impression: shallow inspiration.On (b)(6) 2010: patient underwent stress myoview scan with gated study.Impression: normal stress cardiolite study.On (b)(6) 2010: patient underwent xr barium swallow/esophagus due to atypical chest pain and gerd.Impression: small hiatal hernia and a small area of focal outpouching along the anterior aspect of the distal esophagus.While findings may relate to a stomach fold in this region, focal ulceration is not definitely excluded; mild spasm.On (b)(6) 2010: patient underwent chest x-ray due to pain.Impression: negative low lung volume portable chest.On (b)(6) 2010: patient underwent chest x-ray due to chest pain.Impression: stable mildly low lung volumes.No clear evidence of acute disease.Patient underwent stress myoview scan with gated study due to chest pain.Impression: normal stress cardiolite study.On (b)(6) 2010: patient underwent nm biliary image (hida) gb/ef study due to abdominal pain with nausea and vomiting and fatigue.Impression: findings concerning for acute cholecystitis.The differential diagnosis would also include complete common bile duct obstruction.Patient also underwent us rev iii abre limited abdomen study due to abdominal pain and nausea.Impression: cholelithiasis with no convincing evidence of sonographic evidence of acute cholecystitis; diffuse increased echogenicity of the liver as is commonly seen with diffuse hepatic steatosis (fatty infiltration) or less likely cirrhosis.On (b)(6) 2010: patient underwent ercp ¿ bil/panc x-ray due to the history of gallstones.Impression: ercp.On (b)(6) 2011: patient underwent chest x-ray due to cough and congestion.Impression: no definite acute cardiopulmonary process.Low lung volumes.On (b)(6) 2012: patient underwent ct head without contrast due to dizziness, headaches.Impression: no acute intracranial process.On (b)(6) 2014: patient underwent chest x-ray due to chest pain.Impression: no definite acute abnormality.No interval change.On (b)(6) 2014: patient underwent stress myoview scan with gated study.Impression: large amount of attenuation present affecting the accuracy of the study; moderate reversibility in the anterior, anteroseptal and anteroapical regions suggesting ischemia; inferior attenuation; ejection fraction 63%; this is an intermediate risk study.On (b)(6) 2014: patient underwent ct lumbar spine without contrast.Impression: chronic pars fractures of l5 with associated grade 1 an terolisthesis.Irregular disc osteophytic ridging and post treatment related changes at l5-s1 more prominent on the right side probably some mass effect the right side of the thecal sac and right lateral recess.Severe neural frontal stenosis at l5-s1.No compression fractures.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on: (b)(6) 2004: the patient presented for consultation.On (b)(6) 2004: the patient underwent cath.On (b)(6) 2010: the patient presented for severe heart burn extending into chest pain.On (b)(6) 2010: the patient presented with abdominal pain, bloating, chest pain.The patient underwent stress myoview scan with gated study.Normal.On (b)(6) 2014: the patient presented with chest pain.The patient underwent stress test.On (b)(6) 2014: the patient underwent left heart cath, coronary angiography, left ventriculography.Normal on (b)(6) 2003: patient presented for follow up bug bite.Assessment: spider bite.On (b)(6) 2003: patient presented for follow up bug bite, lower extremity edema and check up on blood pressure.Patient complained of chronic situation and stated that when he was on his feet all day, he had noticed that at the end of the day that his lower legs were swollen.Assessment: spider bite, improved; lower extremity edema; hypercholesterolemia.On (b)(6) 2003: patient presented for follow up of cholesterol as well as bite on his neck and sexual promiscuity.Assessment: impetigo of insect bite; insomnia; high risk sexual behavior.On (b)(6) 2004: patient presented with chest pain that radiated to his back and shoulder.Assessment: chest pain; hyperglycemia; elevated bun and creatinine.Patient underwent chest x-ray due to shortness of breath and chest pain.Impression: the left pleural cavity air fluid level is absent and there is pleural thickening.Lateral decubitus view of the chest is recommended.X-ray also showed following: mild cardimegaly with mild pulmonary venous hypertension.Increased markings at the right lung base may be indicative of an early infiltrate.On (b)(6) 2004: patient presented for consultation with chest discomfort radiating to the left shoulder.Impression: middle aged male with acute renal insufficiency on admission that may have been secondary to nonsteroidal anti-inflammatory drug therapy.On (b)(6) 2004: patient was discharged with following discharge diagnosis: atypical chest pain; mild cardiomyopathy; question of renal insufficiency; glucose intolerance.On (b)(6) 2004: patient underwent gall bladder ultrasound due to chest pain.Impression: normal gall bladder ultrasound.Patient underwent upper gi x-ray due to upper abdominal pain.Impression: normal upper gi study.On (b)(6) 2004: patient presented with diarrhea, off and on for several years.Assessment: irritable bowel disease; hypertension; anxiety & depression.On (b)(6) 2005: patient presented with neck and back pain which was work injury.On (b)(6) 2005: patient underwent mri of lumbar spine.Impression: possible spondylosis with less than grade i spondylolisthesis at the l5-s1 level.Very mild right paracentral l4-l5 herniated-protruded disc with very minimal asymmetric compression on the thecal sac on the right side.Degenerative disc changes.Patient underwent lumbar spine x-ray due to low back pain.Impression: moderate spondylolisthesis at l5 over s1 measuring 7 mm on flexion views and 8 mm on extension view.Three mm posterior spondylolisthesis of l1 over l2.This finding is stable in both flexion and extension views.Patient underwent orbits x-ray due to foreign body to eye.Impression: ap and lateral views of orbits demonstrate no evidence for metallic foreign bodies.On (b)(6) 2005: patient presented with dynamic instability at l5/s1, consistent with his spondylolisthesis with spondylolysis and pars defect, pre-existing condition aggravated by work injury.On (b)(6) 2005: patient presented with back pain, numbness in feet, mild urinary frequency and diarrhea.Patient had swelling of abdominal wall.Diagnoses: abdominal wall abscess; hyperglycemia.On (b)(6) 2005: patient presented with swelling in feet.Diagnoses: htn, edema feet.On (b)(6) 2005: patient presented with back and leg pain.On (b)(6) 2006: patient presented for pre-op clearance.Diagnosis: back pain.On (b)(6) 2006: patient presented for follow up of pain.Mri revealed transverse process spondylolisthesis, spondylolysis, degenerative disc disease, mild at l4/5.On (b)(6) 2006: patient presented with chest discomfort.Diagnoses: chest pain, back pain, depression, fatigue.On (b)(6) 2006:patient underwent following procedures: bilateral l5 laminectomy for gill fragment removal.Bilateral posterior lumbar interbody fusion using saber cages with rhbmp.Aborted pedicle fixation.4intraoperative monitoring sep uppers and emg lowers.On (b)(6) 2006: patient presented with sore throat, fever, cough, minimal expectoration and nausea, chronic back pain.Diagnoses: back pain, urti, depression.On (b)(6) 2006: patient presented with residual numbness in the ball of his foot and in between his toes which continued to improve.There was improvement in leg pain as well.On (b)(6) 2006: patient presented with back pain.Diagnoses: uti, back pain, depression, chronic insomnia.On (b)(6) 2006: patient presented for diagnostic assessment stating that patient could not sleep and was depressed.Diagnostic impression: axis i: dysthymic disorder, late onset.Axis ii: deferred.Axis iii: orthopedic surgery in the form of fusion.Axis iv: unemployment secondary to orthopedic injury.Financial problems.Disorder with workers compensation.Transition to disablement and change of life style.Axis v: gaf: 52.On (b)(6) 2006: patient was admitted with swelling and right foot pain.Impression: cellulitis of his right foot.On (b)(6) 2006: patient presented with swelling and right foot pain.Impression: cellulitis, right foot.Possible staph infection.Depression & anxiety; status post spinal surgery with vertebral fusion.On (b)(6) 2006: patient presented for psychiatric evaluation reported having difficulty sleeping.Diagnostic impression: mood d isorder, secondary to back injury with depressive features.Adjustment disorder, dysthymic disorder.No diagnosis.Chronic back pain status post spinal fusion.Financial problems.Occupational problems.Limited primary support.Current gaf: approximately 60.Patient was discharged with following diagnoses: cellulitis, right foot; depression; obesity; arthritis.On (b)(6) 2006: patient complained of cellulitis right leg.Diagnoses: cellulitis right leg; back pain.On (b)(6) 2006: patient presented for evaluation of dysthymia with anxiety and for medication assessment.On (b)(6) 2006: patient presented for lt si injection under c-arm.On (b)(6) 2006: patient underwent wechsler adult intelligence scale ii and nelson-denny reading test.Diagnostic impression  dysthymic disorder; somatoform disorder not otherwise specified.Borderline intelligence.: c/o overweight; back problems; leg and feet difficulties; neck pain; numbness in extremities; s/p back surgery.Psychosocial stressors.Current gaf: 55 to 59.On (b)(6) 2007: patient underwent mammo diagnostic bilateral due to left breast mass.Impression: no mammographic evidence of breast tissue or malignancy on the right.Mild left gynecomastia.No mammographic evidence of malignancy.Bi-rads: 0.Patient also underwent us breast left unilateral or bilateral.Impression: asymmetric gynecomastia.No sonographic or mammographic evidence of malignancy.Some breast cancer, even when palpable, not detected by mammography.Bi-rads classification: 2.On (b)(6) 2008: patient underwent non-contrast head ct.Impression: no ct evidence of acute intracranial abnormality.On (b)(6) 2008: patient presented with pain and depression.Diagnoses: depression nos.Diagnosis deferred.: allowed industrial condition, obesity, and hypertension.Health issues.Gaf current 60.On (b)(6) 2009: patient underwent mri head without contrast due to history of head pressure with blurred vision.Impression: a few areas of white matter signal abnormality which could relate to migraine headaches, demyelination, chronic microvascular ischemic changes as well as many other etiologies.On (b)(6) 2009: patient presented for follow up of probably benign gynecomastia in the left breast and underwent mammo diagnostic bilateral study.Impression: right breast normal.Acr bi-rads category 1.Left breast benign gynecomastia.Acr bi-rads category 0.30.On (b)(6) 2009: patient underwent nerve conduction velocity study.Impression: normal study.There is no evidence of neuropathy seen.On (b)(6) 2009: patient underwent nerve conduction velocity study and electromyography study.Impression: abnormal study.There is subtle evidence of a bilateral chronic radiculopathy that is difficult to localize further.On (b)(6) 2009: patient underwent mri cervical spine without contrast due to neck pain.Impression: mild multilevel degenerative disc disease.On (b)(6) 2010: patient underwent chest x-ray due to chest pain.Impression: shallow inspiration.On (b)(6) 2010: patient underwent stress myoview scan with gated study.Impression: normal stress cardiolite study.On (b)(6) 2010: patient underwent xr barium swallow/esophagus due to atypical chest pain and gerd.Impression: small hiatal hernia and a small area of focal outpouching along the anterior aspect of the distal esophagus.While findings may relate to a stomach fold in this region, focal ulceration is not definitely excluded.Mild spasm.On (b)(6) 2010: patient underwent chest x-ray due to pain.Impression: negative low lung volume portable chest.On (b)(6) 2010: patient underwent chest x-ray due to chest pain.Impression: stable mildly low lung volumes.No clear evidence of acute disease.Patient underwent stress myoview scan with gated study due to chest pain.Impression: normal stress cardiolite study.On (b)(6) 2010: patient underwent nm biliary image (hida) gb/ef study due to abdominal pain with nausea and vomiting and fatigue.Impression: findings concerning for acute cholecystitis.The differential diagnosis would also include complete common bile duct obstruction.Patient also underwent us rev iii abre limited abdomen study due to abdominal pain and nausea.Impression: cholelithiasis with no convincing evidence of sonographic evidence of acute cholecystitis.Diffuse increased echogenicity of the liver as is commonly seen with diffuse hepatic steatosis (fatty infiltration) or less likely cirrhosis.On (b)(6) 2010: patient underwent ercp il/panc x-ray due to the history of gallstones.Impression: ercp.On (b)(6) 2011: patient underwent chest x-ray due to cough and congestion.Impression: no definite acute cardiopulmonary process.Low lung volumes.On (b)(6) 2012: patient underwent ct head without contrast due to dizziness, headaches.Impression: no acute intracranial process.On (b)(6) 2014: patient underwent chest x-ray due to chest pain.Impression: no definite acute abnormality.No interval change.On (b)(6) 2014: patient underwent stress myoview scan with gated study.Impression: large amount of attenuation present affecting the accuracy of the study.Moderate reversibility in the anterior, anteroseptal and anteroapical regions suggesting ischemia.Inferior attenuation.Ejection fraction 63%.This is an intermediate risk study.On (b)(6) 2014: patient underwent ct lumbar spine without contrast.Impression: chronic pars fractures of l5 with associated grade 1 an terolisthesis.Irregular disc osteophytic ridging and post treatment related changes at l5-s1 more prominent on the right side probably some mass effect the right side of the thecal sac and right lateral recess.Severe neural frontal stenosis at l5-s1.No compression fractures.Curently the patient has stabbing pain in his lower back that radiates to the middle back occasionally.Patient also experiences numbness patient was admitted to the facility for ercp, stress test, swallow study, chest pain and heart cath, mva, syncope/confusion, stress test, radiology, si joint injections, cellulitis, and spinal fusion.
 
Event Description
It was reported on, (b)(6) 2009 the patient had the following ros: recent weight gain, headaches that begin in the neck, swelling of the feet, asthma, and constipation, sexual difficulty, left breast pain, nervousness, insomnia and musculoskeletal complaints.Impression: chronic low back pain, chronic lower extremity radicular complaints, post laminectomy syndrome.Status post l5/s1 fusion in 2006.No clinical evidence of radiculopathy or myelopathy.Morbid obesity.Chronic cervical pain.History of cervical degenerative disc disease by history.History of bilateral hand numbness consistent with carpal tunnel syndrome.No clinical evidence of carpal tunnel syndrome.Asthma.Hypercholesterolemia.Erectile dysfunction.Hypertension.Osteoarthritis.Depression with no history of suicidal ideation or suicide attempt.Insomnia recently improved.On (b)(6) 2010: patient presented in er due to chest pain.Patient underwent chest x-ray due to pain.Impression: negative low lung volume portable chest.On (b)(6) 2010: patient was diagnosed with copd; hiatal hernia, hyperlipidemia, hypertension, depression, neck sprain and strain, degen eration of cervical intervertebral disc, degeneration of lumbar or lumbosacral intervertebral disc, depressive disorder, lumbago, postlaminectomy syndrome, lumbar region.On (b)(6) 2010: patient underwent ercp - bil/panc x-ray due to the history of gallstones.Impression: ercp.Assessment: choledocholithiasis, s/p ercp with stone extraction and sphincteromy.Elevated lft's - now improving.S/p cholecystectomy.On (b)(6) 2010 the patient had neck sprain and strain, degeneration of cervical intervertebral disc, degeneration of lumbar intervertebral disc, depressive disorder, lumbago, post laminectomy syndrome, lumbar region, congenital spondylolisthesis, hiatal hernia, hyperlipidemia, hypertension, depression, copd, ruq pain,.Elevated liver enzymes, choledocholithiasis unresolved.On (b)(6) 2011: patient presented with complaint of hyperlipidemia, htn, depression, copd, ruq pain, elevated liver enzymes, choledocholithiasis.On (b)(6) 2011: patient presented for medication refill.On (b)(6) 2011: patient got diagnosed with asthma with acute exacerbation, morbidly obese, prediabetes, hyperlipidemia (hld).On (b)(6) 2011: patient presented for followup of dyspnea and wheezing.Assessment: asthma; dyspnea; weight loss.On (b)(6) 2011: patient presented with complaint of hypertension and rash.On (b)(6) 2011: patient presented with complaint of cough, sinus congestion, and bronchitis.Assessement: asthma exacerbation.On (b)(6) 2012, (b)(6) 2013: patient presented with complaint of hypertension and dizziness.On (b)(6) 2013: patient presented with complaint of breast pain.Assessment: dizziness, environmental allergies, breast edema.On (b)(6) 2013: patient presented with trouble of whistling sound in ears and underwent audiology balance testing.On (b)(6) 2013: patient presented with complaint of otalgia, pharyngitis, and cough.Assessment: otitis externa, pharyngitis, bronchitis, cough, wheezing, fatigue, dizziness.On (b)(6) 2014: the patient presented with chest pain.The patient underwent stress test.Assessment: chest pain.Hypertension, hyperlipidemia, gerd, chole.On (b)(6) 2014: patient presented with complaint of hypertension and back pain.On (b)(6) 2014: patient presented with complaint of back pain.On (b)(6) 2014: patient presented for med refill.On (b)(6) 2015: patient presented with complaint of hypertension, rectal bleeding.On (b)(6) 2015 the patient was diagnosed for diarrhea, rectal pain, abdominal cramping.The patient with pre-op diagnosis: colon cancer screening, chronic gerd to look for esophagitis and barrett's mucosa.Underwent colonoscopy, upper endoscopy and biopsies.Post-op diagnosis: ge junction at 43 cm, small hiatal hernia, gastroduodenitis, no esophagitis or barrett seen.On (b)(6) 2015: patient was diagnosed with hypertension and hiatal hernia and had complaint of cough.Assessment: acute bronchitis; acute sinusitis; cough.On (b)(6) 2015, patient presented for office visit due to cough nasal congestion and for medication refill.On (b)(6) 2016, patient presented for office visit due to back pain, hypertension and cough.
 
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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 Key3881872
MDR Text Key17576348
Report Number1030489-2014-02784
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 05/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/16/2016
Was Device Evaluated by Manufacturer? No
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; Disability;
Patient Age00044 YR
Patient Weight118
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