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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthritis (1723); Bronchitis (1752); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Tingling (2171); Dysphasia (2195); Stenosis (2263); Discomfort (2330); Depression (2361); Numbness (2415); Neck Pain (2433); Nasal Obstruction (2466); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Weight Changes (2607); Difficulty Chewing (2670)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a plif at l5-s1 using a cage and a plf at l5-s1.It was reported that the fusion cage was packed with rhbmp-2/acs.Reportedly, rhbmp-2/acs was also placed in the anterior disc space and in the lateral gutters.Reportedly, sometime following her surgery, the patient experienced new and/or worse pain.Specifically, the patient has experienced progressive, disabling pain in her lower back, radiating to her legs.
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Manufacturer Narrative
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Concomitant products: cage (implant: (b)(6) 2010).(b)(4).Neither the device nor applicable imaging study films or patient medical records 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/used 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.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2011 the patient presented for follow up for opiate dependence.Assessment: opiate dependence; anxiety/depression; (b)(6) 2015, the patient presented for an evaluation for opiate dependence with medication assisted treatment.Assessment: opiate dependence; medication assisted treatment on an unknown date the patient presented with complaints of joint pain, fatigue and positive ana.On (b)(6) 2009 the patient presented with complaints of snoring, tiredness and fatigue.
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Manufacturer Narrative
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(b)(4).
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Event Description
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On (b)(6) 2009: the patient underwent "cpap" titration.Impression: obstructive sleep apnea.On (b)(6) 2010 the patient telephonically communicated her complaints of arthritis in her lower back and neck which is keeping her up at night.The patient has no relief from current medication ultram.Physical examination revealed abnormal diminished rom at c spine and ls spine.On (b)(6) 2010 the patient came for a follow-up due to headache and neck pain.Impressions: posttraumatic cervical strain; posttraumatic cervical radiculopathy; posttraumatic lumbar strain; chronic posttraumatic headaches.On (b)(6) 2010 the patient underwent nerve conduction study report due to pain, tingling, numbness and weakness in the right upper extremity and both lower extremities with history of recent motor vehicle accident.Conclusion: essentially normal study of both lower extremities.On (b)(6) 2010 the patient was diagnosed for lumbar degenerative disc disease.On (b)(6) 2010: the patient presented with the following admitting diagnosis: lumbar degenerative disc disease.On (b)(6) 2010 the patient underwent funduscopic examination which was limited but no abnormalities were appreciated.Musculoskeletal: faber negative.Straight leg raising negative.Rom cervical spine: normal.Rom lumbar spine: diminished in flexion and extension secondary to discomfort.Imaging studies: severe lumbar degenerative disk disease at l5-s1.We discussed l 5 -5 1 fusion with an anterior interbody graft and posterior lateral fusion.She understands this is a grade area for fusion; however, she does have a severe radiculopathy.On (b)(6) 2010 the patient was status post l5-s1tlif and still has some anterior thigh discomfort.On (b)(6) 2011: patient underwent lumbar spine x-ray due to pre-op ddd.Impression: posterior surgical fusion at the lumbosacral junction in a patient with transitional, mostly sacralized l5 vertebra.On (b)(6) 2011: she suffers from chronic pain from fibromyalgia and degenerative disk disease of the lumbar spine.On (b)(6) 2011, patient presented for rheumatology follow-up.Patient reported pain in hands, feet and lumbar spine.Assessment: positive ana.No evidence was found for connective tissue disease; polyarticular joint pain; sleep disturbances and sleep apnea.On (b)(6) 2011 the patient was diagnosed for bipolar ii disorder and panic disorder.She has had same anxiety and depression going back to her teens.Her depression has worsened over the last two years where it has become severe.She also has had insomnia, decreased energy, withdrawal from others and problems concentrating.Her anxiety has progressed to the point where she is having panic attack characterized by a heightened sense of anxiety, shortness of breath, chest pain, increased heart rain that are occurring a few times a week.On (b)(6) 2011 the patient was diagnosed for significant lumbar spine pain, ployarticular joint pain, sleep disturbance with sleep apnea and fatigue.Patient also has degenerative arthritis in the feet and that has caused some problems walking.She significantly also has severe anxiety and recently was diagnosed as being bipolar.The patient also has panic attacks.
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Manufacturer Narrative
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Concomitant products: screws, rod, set screw, graft extender/expander (implant (b)(6) 2010) (b)(4).
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Event Description
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It was reported that the patient was admitted with pre-op diagnosis of severe intractable back pain, lumbar degenerative disk disease with radiculopathy at l5-s1 for which patient underwent following procedures: 1.Bilateral inferior laminotomy l5, superior laminotomy s1, medial facetectomy for decompression of bilateral l5 and s1 nerve root.2.Interbody arthrodesis using peek cage with rhbmp-2/acs and local morcellized bone graft.3.Transpedicular hardware, bilateral l5 and s1 insertion.4.Posterolateral arthrodesis using rhbmp-2/acs with compression resistant matrix and local morcellized bone graft.Per the op notes, a peek cage was sized and packed with rhbmp-2/acs and local morcellized bone graft was placed into the interbody space, ensuring that the neural elements were protected.Prior to placement of the peek cage, morcellized bone graft mixed with small bits of rhbmp-2/acs sponges were packed in the anterior interbody space.After the peek cage was inserted, local morcellized bone graft was placed without rhbmp-2/acs.The left decorticated facet was packed with rhbmp-2/acs and local morcellized bone graft.The lateral gutters were packed with compression resistant matrix, rhbmp-2/acs and local bone graft to perform the posterior lateral fusion.After x-rays revealed good position of the transpedicular screws and interbody cage, a connecting rod was placed.Tisseel was placed over the facetectomy/discectomy on th e right l5-s1, to seal the interbody graft/rhbmp-2/acs.The patient also underwent for multiple x-rays of lumbar spine due to hardware placement, l5-s1 tlif procedure, intra-op, which demonstrated that: there is a surgical instrument seen projected over the posterior elements at the l5 level; intrapedicular screws are present at the l5-s1 level.Alignment appeared anatomic and the hardware appeared intact; pedicle screws have been placed at l5 and s1 stable from earlier intraoperative film.An interbody fusion device has now been placed in good position; there is a surgical instrument seen projected over the posterior soft tissues at the s1 level.No patient complications were noted.(b)(6) 2010: the patient was discharged after undergoing l5-s1 decompression and fusion procedure.Her incision was without drainage.(b)(6) 2010 the patient was status post l5-s1 tlif and still has some anterior thigh discomfort.(b)(6) 2011 the patient still has low back pain with radiation into his right hip especially when she is walking.Radiographs were reviewed and it showed development of posterior, lateral and interbody fusion.(b)(6) 2011 the patient was admitted with the diagnosis of lumbar disc degenerative disease status post l5-s1.Aquatic therapy, hep were given to patient.(b)(6) 2011 the patient underwent x-ray of the chest due to cough.Impression: normal chest and there are degenerative changes of the dorsal spine.(b)(6) 2011 the patient presented for a follow up visit and complained of pain in right hip, mid back of leg and front of right leg.Range of motion of lumbar spine was slightly diminished secondary to discomfort.She still has some right anterior thigh pain.(b)(6) 2011 the patient complained of constant pain in low back and right low extremity, numbness/tingling.She was discharged from the physical therapy.(b)(6) 2011 the patient underwent x-ray of the lumbar spine.Impression: stable posterior fusion with interpedicular screws and rods at l5-s1 level.(b)(6) 2011 the patient presented for a follow up on pain in low back.Range of motion of lumbar spine is slightly diminished.Radiographs of lumbar spine dated (b)(6) 2011 were reviewed and it showed good position of transpedicular hardware and interbody graft.(b)(6) 2011 and (b)(6) 2011 the patient presented with diagnosis of bipolar disorder neck.(b)(6) 2011 the patient underwent lumbar spine ct without contrast due to lumbar ddd.Impression: postsurgical changes of posterior lumbar fusion at l5-s1 with anatomic alignment and no evidence of hardware complication.There was mild narrowing of the right neuroforamen at l5-s1.(b)(6) 2011 the patient presented for a follow up visit and complained of spasms at times.Ct scan of lumbar spine was reviewed and it showed that the she was developing a solid interbody and posterior arthrodesis at l5-s1.(b)(6) 2011 the patient presented with complaints of dysphagia and reflux esophagitis, final diagnoses: 1.Gastric biopsy: mild gastritis with no helicobacter, 2.Esophageal biopsy: benign esophageal mucosa with esophagitis with no dysplasia.The patient underwent gastroscopy procedure with post-op diagnoses of hernia, gastritis, esophagitis.(b)(6) 2011 the patient presented with cough and underwent the following studies: spirometry; lung volumes, plethysmograph.Impression: normal spirometry with normal mvv.Lung volumes are normal.Dlco is mildly decreased.The patient underwent ultrasound study of the thyroid due to dysphagia and thyromegaly.Impression: a 3 mm nodule within the mid to lower pole of the right lobe.(b)(6) 2012 the patient presented with multiple complaints chronic cough, sob with climbing stairs, swelling hands/feet, headache, and ear pain.(b)(6) 2012 the patient presented with admit diagnosis of cough.The patient underwent ct of chest.Impression: no acute findings.Two incidental nodules were detected near the right costophrenic angle and a few tiny reticular densities in each lung base were suggestive of small interstitial scars.The patient underwent complete 2d echocardiogram, m-mode, color flow and doppler.Conclusion: left ventricle was normal in size and function with an ejection function of 70%.Stage 1 diastolic dysfunction was seen.The atrium was mildly dilated.Trace tricuspid regurgitation observed.(b)(6) 2012 the patient presented after falling about three weeks ago and hurt her right foot.The patient was positive for fatigue, weight loss (12 lbs), anxiety, depression and back pain.Assessment: anxiety; depression; bipolar disorder; cough; gerd; allergic rhinitis; other and unspecified hyperlipidemia; benign neoplasm of thyroid glands.(b)(6) 2012 the patient underwent ultrasound study of the thyroid gland.Impression: stable 3 mm hypoechoic nodule in the mid to lower pole of the right lobe.(b)(6) 2012 the patient presented with cough and chest pain.The pain hurts with coughing and taking deep breaths.The pain radiated across her entire chest and sternally.She also reported dizziness and anxiety.She was very tender to palpation of her entire chest wall and flinches with touch.Assessment: cough; pleuritic pain; other non specific abnormal finding of lung field.(b)(6) 2012 the patient presented for a follow up on chronic medical conditions.The patient was positive for fatigue, anxiety and de pression.Assessment: cough; non toxic uninodular goiter; bipolar disorder; cough; anxiety; depression; allergic rhinitis; other and unspecified hyperlipidemia.(b)(6) 2012 the patient presented for a follow up on chronic medical conditions and complained of persistent low back pain.The pain is sharp, radiates into right lumbar area and into right hip.The patient reported weight gain of 7 lbs and was positive for anxiety, depression and back pain.There were muscle spasm and tenderness with palpation over l3-5 area as well as in the right lumbar paraspinal region.Assessment: gerd; lumbago; cough; anxiety; depression; allergic rhinitis; other and unspecified hyperlipidemia; bipolar disorder.(b)(6) 2013 the patient underwent mri of the lumbar spine.Impression: posterior lumbar fusion spanning l5-s1.Surgical hardware artifact limits evaluation of this level.Within this level there is no evidence of focal disk herniation.There is however suggestion of mild bilateral neural foraminal narrowing.(b)(6) 2013 the patient presented for a follow up and complained of anxiety/depression.The patient was positive for fatigue, anxiety, depression, dizziness and back pain.Assessment: gerd; benign neoplasm of thyroid glands; cough; anxiety; depression; other and unspecified hyperlipidemia; bipolar disorder; other non specific abnormal finding of lung field.(b)(6) 2013 the patient presented for a follow up on anxiety/depression/bipolar disorder.The patient reported irritability, anxiety, depression, difficulty concentrating, psychiatric symptoms, inability to focus, mood swings, paranoia, and fearfulness.She complai ned of pain around right eye.Assessment: anxiety; depression; bipolar disorder; gerd; other non-specific abnormal finding of lung field; non-toxic uninodular goiter; lumbago; unspecified vitamin d deficiency.(b)(6) 2014 the patient presented with laceration of right forehead, 8 cm full thickness down to forehead periosteum.The patient underwent debridement and layered repair of forehead laceration, 8 cm procedure the patient underwent ct scan of the head without contrast.Ct impression: soft tissue injury to the scalp.Negative intracranial exam.The patient also underwent ct scan of the cervical spine.Impression: degenerative change.(b)(6) 2014 the patient presented for a follow up on chronic medical conditions and complained of low back pain with radiation into bilateral lower extremities.Back pain is associated with weakness of bilateral lower extremities worse with standing, walking and excessive sitting.The patient was positive for dizziness, extremity weakness, anxiety, depression and back pain.There was tenderness and mild pain with motion in lumbar spine.Assessment: anxiety; depression; gerd; attention deficit disorder of childhood with hyper; bipolar disorder; counselling on substance use and abuse; other and unspecified hyperlipidemia; other non specific abnormal finding of lung field.(b)(6) 2014 the patient underwent mri of the lumbar spine.Impression: overall, stable appearance of the lumbar spine since the comparison study.There is degenerative disk disease at l4-5 and l5-s1 levels with mild resultant neural foraminal stenosis.
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Event Description
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It was noted that on (b)(6) 2011: the patient presented with back pain.Aquatic therapy initiated.On (b)(6) 2011 she has had no significant improvement of her axial back pain.Assessment: status post transforaminal lumbar interbody fusion l5-s1.On (b)(6) 2011, the patient presented with severe depression, panic disorder, psychotic symptoms and manic symptoms.Associated symptoms also included auditory and visual hallucinations, paranoid, crying spells, euphoric mood, spending sprees, racing thoughts, rapid speech and hyper mood.Assessment: axis i: bipolar ii disorder, panic disorder without agoraphobia, "adhd" predominantly inattentive type, obsessive compulsive disorder, post-traumatic stress disorder; axis ii: no diagnosis; axis iii: tension headache, ovarian cyst, hypercholesterolemia, mitral valve prolapse, weight gain.On (b)(6) 2011, (b)(6) 2012: the patient presented with moderate depression, occasional panic disorder, psychotic symptoms and manic symptoms.Associated symptoms also included crying spells, anxiety, shortness of breath, chest pains, increased heart rate, euphoric mood, racing thoughts, rapid speech, auditory hallucinations, paranoid and hyper mood.Assessment: axis i: bipolar ii disorder, panic disorder without agoraphobia, "adhd" predominantly inattentive type, obsessive compulsive disorder, post-traumatic stress disorder, marital problems; axis ii: no diagnosis; axis iii: tension headache, ovarian cyst, hypercholesterolemia, mitral valve prolapse, slight hyponatremia; axis iv: psychological stressors-moderate.On (b)(6) 2011, (b)(6) 2012, (b)(6) 2013, (b)(6) 2014: the patient presented for opiate dependence.Assessment: opiate dependence, on tapering course of suboxone.History of back surgery with chronic back pain.History of depression, stable on the current medication.On (b)(6) 2011: the patient presented for follow up office visit, status post transforaminal lumbar interbody fusion.Previous ct scan was reviewed.It appeared that she was developing a solid interbody and posterior lateral arthrodesis at l5-s1.On (b)(6) 2012: the patient presented with opiate dependence and depression.On (b)(6) 2012: the patient presented with moderate depression, occasional panic disorder, psychotic symptoms and manic symptoms.Associated symptoms also included social withdrawal, crying spells, euphoric mood, racing thoughts and hyper mood.Assessment: axis i: bipolar ii disorder, panic disorder without agoraphobia, "adhd" predominantly inattentive type, obsessive compulsive disorder, post-traumatic stress disorder, marital problems; axis ii: no diagnosis; axis iii: tension headache, ovarian cyst, hypercholesterolemia, mitral valve prolapse, drowsiness and wobbly gait on higher dose of depakote.On (b)(6) 2012: the patient presented for follow up for her opiate dependence.She complained of increased stress and migraine headaches.On (b)(6) 2012, (b)(6) 2013: the patient presented for routine follow-up and had complaints of moderate to severe depression, occasional panic disorders and manic symptoms.Associated symptoms also included social withdrawal, decreased concentration and crying spells.Assessment: axis i: bipolar ii disorder, panic disorder without agoraphobia, "adhd" predominantly inattentive type, obsessive compulsive disorder, post-traumatic stress disorder; axis ii: no diagnosis; axis iii: hypertension, tension headache, chronic back pain, ovarian cyst, hypercholesterolemia, mitral valve prolapse, am grogginess.On (b)(6) 2013: the patient presented for routine follow-up and had complaints of moderate and continuous depression, occasional panic disorder and manic symptoms.Associated symptoms also included social withdrawal and crying spells.Assessment: axis i: bipolar ii disorder, panic disorder without agoraphobia, "adhd" predominantly inattentive type, obsessive compulsive disorder, post-traumatic stress disorder, marital problems; axis ii: no diagnosis; axis iii: hypertension, tension headache, chronic back pain, ovarian cyst, mitral valve prolapse.On (b)(6) 2013: the patient presented for follow up on opiate dependence.The patient had a fall where she sustained facial abrasions.On (b)(6) 2013: the patient presented for routine follow-up with the complaints of depression, panic disorder, manic symptoms and psychotic symptoms.Associated symptoms also included anxiety, shortness of breath, crying spells, chest pains, increased heart rate, visual hallucinations, euphoric mood, hyper mood and spending sprees.Assessment: axis i: bipolar ii disorder, panic disorder without agoraphobia, (:adhd" predominantly inattentive type, obsessive compulsive disorder, marital problems; axis ii: no diagnosis; axis iii: hypertension, tension headache, chronic back pain, ovarian cyst, mitral valve prolapse.On (b)(6) 2013: the patient presented with moderate and continuous depression, panic disorder, manic symptoms and psychotic symptoms.Associated symptoms also included social withdrawal, anhedonia, shortness of breath, anxiety, chest pain, increased heart rate, hyper mood, rapid speech, paranoid, spending sprees and racing thoughts.Assessment: axis i: bipolar ii disorder, panic disorder without agoraphobia, "adhd" predominantly inattentive type, obsessive compulsive disorder; axis ii: no diagnosis; axis iii: hypertension, tension headache, chronic back pain, ovarian cyst, mitral valve prolapse.On (b)(6) 2013, (b)(6) 2014: the patient presented with moderate depression, panic disorder, psychotic symptoms and manic symptoms.The symptoms also included anxiety, shortness of breath, chest pain, and increased heart rate.Assessment: axis i: bipolar ii disorder, panic disorder without agoraphobia, "adhd" predominantly inattentive type, obsessive compulsive disorder; axis ii: no diagnosis; axis iii: hypertension, tension headache, chronic back pain, ovarian cyst, mitral valve prolapse.On (b)(6) 2014 the patient presented for a follow up on chronic medical conditions and complained of low back pain with radiation into bilateral lower extremities.Back pain is associated with weakness of bilateral lower extremities worse with standing, walking and excessive sitting.The patient was positive for dizziness, extremity weakness, anxiety, depression and back pain.There was tenderness and mild pain with motion in lumbar spine.Assessment: anxiety; depression; gerd; attention deficit disorder of childhood with hyper; bipolar disorder; counselling on substance use and abuse; other and unspecified hyperlipidemia; other non specific abnormal finding of lung field.The patient underwent mri of lumbar spine without contrast.Impression: overall, stable appearance of the lumbar spine since the comparison study, dated (b)(6) 2013.There was degenerative disk disease at the l4-l5 and l5-s1 levels with mild resultant neural foraminal stenosis.On (b)(6) 2014: the patient presented with severe depression, panic disorder and hyper mood.Assessment: axis i: bipolar ii disorder, panic disorder without agoraphobia, "adhd" predominantly inattentive type, obsessive compulsive disorder; axis ii: no diagnosis; axis iii: hypertension, tension headache, chronic back pain, ovarian cyst.On (b)(6) 2014: the patient presented for opiate dependence, co-morbid chronic cervicalgia and co-morbid depression.On (b)(6) 2014: the patient presented for follow up on opiate dependence and continued pain syndrome.Celebrex was started.On (b)(6) 2014: the patient presented with severe depression and panic disorder.The patient also had complaints of shortness of breath, chest pain, increased anxiety, decreased energy and increased heart rate.Manic symptoms also included hyper mood, rapid speech, racing thoughts and spending sprees.Assessment: axis i: bipolar ii disorder, panic disorder without agoraphobia, "adhd" predominantly inattentive type, obsessive compulsive disorder; axis ii: no diagnosis; axis iii: hypertension, tension headache, chronic back pain, ovarian cyst.On (b)(6) 2014 the patient presented with positive "ana" diffuse joint pain and stiffness, excessive fatigue ongoing for years.Physical examination showed decreased range of motion of neck, tenderness over lumbar spine, paraspinal muscles diffusely tender, multiple tender points (14/18 positive).Assessment: osteoarthritis and degenerative disc disease with resultant chronic pain and stiffness.Fibromyalgia.Depression/anxiety.Bipolar disorder.Long term "nsaid" use.Mild lft elevation.Fatigue.Positive "ana".No clinical evidence of connective tissue disease, lupus or rheumatoid arthritis.Vitamin d deficiency.Sleep apnea intolerant to cpap.Gastroesophageal reflux disease.Prior lumbar surgery (2010).Hypertension.The patient underwent various lab examinations.On (b)(6) 2015 the patient presented for recheck of fibromyalgia.Symptoms included myalgias, arthralgias, generalized fatigue, widespread pain, diffused tenderness and morning stiffness.Pain was located in the left occipital area, left side of neck, left shoulder girdle, left pectoral area, left upper back, left mid back, left low back, left pelvic girdle, left upper extremity, left lower extremity, left sacroiliac region, left gluteal area and on their right counterparts.The patient described the pain as aching, moderate in severity and unchanged.Musculoskeletal examination showed 18 of 18 tender points were present.Assessment: osteoarthritis and degenerative disc disease with resultant chronic pain and stiffness.Fibromyalgia.Depression/anxiety.Bipolar disorder.Long term "nsaid" use.Mild lft elevation.Fatigue.Positive "ana".No clinical evidence of connective tissue disease, lupus or rheumatoid arthritis."h/o" opioid abuse.The patient underwent various lab examinations.
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Manufacturer Narrative
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(b)(6) 2006 head ct no spinal pathology imaged (b)(6) 2007 lumbar mri slight desiccation and bulge at l5 otherwise discs appear normal.Conus sits behind l1/2.No canal stenosis is noted.Axial views show normal facets without foraminal stenosis, normal posterior elements and posterior musculature.No signs of previous surgical intervention.(b)(6) 2008 right wrist x-rays ap of the right thumb cmc joint appears normal.Wrist films also normal.Right hand x-rays ap, lateral and obliques appear normal.Mild narrowing of the radiocarpal joint is noted.(b)(6) 2008 mammogram no spinal pathology imaged (b)(6) 2009 bone scan whole body scan is normal with exception of right l5 posterolateral area where there is increased uptake.Alignment appears normal (b)(6) 2009 thoracic spine x-rays ap, lateral and swimmer's views show normal kyphosis without profound arthritis or deformity.Lung fields are normal.Cardiac shadow is normal.Cervical ct axial, coronal and sagittal studies are reviewed.The soft tissue shadow suspected on the right at c5/6 appears resolved.Sagittal and coronal reconstructions show no subluxation or advanced arthritis.The canal contents cannot be verified with certainty.Right shoulder x-rays three views are essentially normal.No arthritis, normal intervals and the humerus is well positioned within the glenoid.(b)(6) 2010 shoulder mri no spinal pathology imaged.Cysts are seen at the ac joint, and fluid collection is seen anteriorly.(b)(6) 2010 thallium scan cardiac scan with no spinal pathology imaged.(b)(6) 2010 lhc cardiac catheterization no spinal pathology imaged (b)(6) 2010 lumbar mri desiccated l5 disc without herniation.Slight posterior bulge noted without stenosis.Alignment is normal.Disc spaces are otherwise well maintained.Conus is behind l2.Axial views show severe facet arthritis at l5 worse on the right.Minor subluxation is see as well.Desiccation of the l5 disc is verified without hnp or stenosis.(b)(6) 2010 chest x-ray pa and lateral views are normal.Cardiac, pulmonary and bony shadows are normal.Spine is not well visualized.Lateral shows mild anterior osteophytes at about t8 region with some increased lordosis above t6 (b)(6) 2010 mammogram no spinal anatomy imaged (b)(6) 2010 lumbar intra-operative x-rays series of ap and lateral views are shown the first two are preop and normal, the second shows a localization probe at the level of the l5 pedicle.The next shows pedicle screws in l5 and s1 with cerebellar retractors in place above and below.Next lateral shows screws and spacer in place with widening of the l5 disc.Final ap and lateral studies show final construct with metallic rods and screws spanning l5/s1 with interbody spacer within the l5 disc.(b)(6) 2011 lumbar x-ray series ap and lateral studies show construct with metallic rods and screws spanning l5/s1 with interbody spacer within the l5 disc.Oblique views show good position of rods and screws within the l5 level.Ap also shows presence of posterolateral fusion bone between l5 and s1.(b)(6) 2011 chest x-ray pa and lateral views are normal.Cardiac, pulmonary and bony shadows are normal.Spine is not well visualized.Lateral shows mild anterior osteophytes at about t8 region with some increased lordosis above t6 (b)(6) 2011 lumbosacral x-rays ap and lateral studies show construct with metallic rods and screws spanning l5/s1 with interbody spacer within the l5 disc.Oblique views show good position of rods and screws within the l5 level.Ap also shows presence of posterolateral fusion bone between l5 and s1.(b)(6) 2011 mammogram no spinal anatomy imaged.(b)(6) 2011 lumbar ct view of l5/s1 construct reviewed.Screws are well positioned and spacer sits within the disc space slightly eccentric to the right.Fusion appears to be solid.Heterotopic bone is clearly seen along the insertion track of the l5 spacer and occupies the area normally occupied by the l5 root.The root is laterally displaced slightly.Other imaged levels appear normal.(b)(6) 2011 chest x-ray pa and lateral views are normal.Cardiac, pulmonary and bony shadows are normal.Spine is not well visualized.Lateral shows mild anterior osteophytes at about t8 region with some increased lordosis above t6 (b)(6) 2011 head/neck us study suggests small notule within thyroid however no spinal anatomy is imaged (b)(6) 2012 thoracic ct chest and upper abdomen are imaged.Osteophytes previously seen in the mid to upper thoracic segments are now clearly seen anterolaterally on the right.No cord compression is clearly seen.Spine/rib relationships appear intact.(b)(6) 2012 tte doppler ultrasound no spinal pathology imaged (b)(6) 2012 mammogram no spinal pathology imaged head-neck ultrasound no spinal pathology imaged (b)(6) 2013 mammogram no spinal pathology imaged (b)(6) 2013 thoracic ct non contrasted study of chest shows no fracture, tumor, hnp etc.Spinal canal contents were not well visualized.Overall study appears normal.Sagittal reconstructions show anterior spurring from about t7 to t10 lumbar mri stir sagittal images shows previous fusion at l5/s1 with pedicle screws, rods and single spacer within the l5 disc.The lumbar lordosis is normal, conus is at l1/2, and no stenosis is appreciated.Some posterior soft tissue edema persists associated with the previous posterior fusion surgery.Axial views show distortion of the right l5 root foramen related to placement of spacer through this area (b)(6) 2014 head ct no spinal pathology imaged cervical ct bony anatomy appears normal with minimal arthritic changes.Right c5/6 level may have an hnp although without contrast very little can be clearly seen within the canal.(b)(6) 2014 lumbar mri interval development of a very small synovial cyst is seen associated with the right l4/5 facet.Bone is seen in the area of the right l5 root and its foramen.Compression of the l5 root cannot be verified.Other levels and the normal lordosis appear to be maintained.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 1987 patient was diagnosed pre-operatively with: nasal deformity, inferior turbinate hypertrophy with obstruction, split right ear lobule, and underwent septorhinoplasty, partial trimming of inferior turbinates, repair of split right ear lobule.On (b)(6) 1988 patient was diagnosed pre-operatively with: residual right nasal obstruction secondary to septal deviation and underwent ab breviation septoplasty.On (b)(6) 1998 patient presented 4 days post her motor accident.Her physical examination revealed the following: closed right nasal bone fracture; nasal septal deviation; multiple facial abrasions and contusions; right greater than left periorbital ecchymosis; otalgia, most likely secondary to tmj capsulitis; normal hearing.On (b)(6) 1998 the patient presented with the pre op diagnosis of closed depressed right nasal bone fracture, status post motor vehicle accident.The patient underwent close reduction of depressed right nasal bone fracture with external fixation.No complications were reported.On (b)(6) 1998 patient presented 1 week status post closed reduction of nasal bone fracture with external fixation.Impression: sinusitis; tmj capsulitis; closed nasal bone fracture; nasal septal deviation; bilateral timitus.On (b)(6) 1998 the patient was presented for office visit with blurred vision in her right eye.Impressions: periorbital trauma and contusion; refractive error.On (b)(6) 1998 patient presented 5 weeks status post closed reduction of nasal bone fracture.Her headaches continue in the frontal region behind the right eye.Impression: tmj capsulitis; cephalgia secondly to # 1; nasal septal deviation.On (b)(6) 1998 patient underwent mri of the lumbar spine.Conclusion: at l5-s1, there is disc desiccation with high intensity zone annular tear far posterolaterally left side in the medial 'foramen with mild broad-based posterior annular bulge, no associated1 neural impingement.There is facet arthrosis bilaterally; transitional s1 segment with bilateral s1-2 pseudoarthrosis.On (b)(6) 1998 patient also underwent mri of the cervical spine with sedation.Conclusion: mild posterior central annular bulges at c5-6 and at c6-7; mild right posterolateral disc bulge c3-4, no neural impingement.On (b)(6) 1998 patient underwent mr of skull base <(>&<)> temporomandibular joints.Conclusion: left tmj: stage 1 early internal derangement; right tmj: morphologically normal-appearing temporomandibular joint structures.On (b)(6) 1998 the patient was presented for office visit with constant frontal headaches, constant jaw pain, ear pain, neck pain, dizziness, problems with balance, shoulder pain and low back pain.On (b)(6) 1999 patient presented for reevaluation of her headaches and complained that she still has pain across the nasal dors1m1 and pressure in that area as well.She states she has daily headaches and feels that part of this is related to her nasal pain, as well as her tmj pain.She still has problems with tinnitus.On (b)(6) 1999 patient presented for reevaluation of her headaches and complained that she continued to have headaches, mid facial pain and pressure, pain over the nasal dorsum, tmj pain.Impression of physical examination: bilateral ethmoid, bilateral maxillary, and bilateral sphenoid sinusitis; nasal septal deviation; cephalgia secondary to # 1.On (b)(6) 1999 patient presented for reevaluation and complained that she continued to have sinus headaches, post nasal drainage, mid facial pain - and pressure, nasal congestion and occasional epistaxis.Impression of physical examination: chronic sinusitis; mild nasal septal deviation; tmj capsulitis.On (b)(6) 1999 the patient was presented for office visit with mid facial pain, pressure and headaches.Impressions: chronic bilateral maxillary, bilateral ethmoid, and left sphenoid sinusitis; nasal septal deviation.On (b)(6) 1999 patient presented for follow-up on her 6 days status post septoplasty, bilateral maxillary antrostomies, bilateral ethmoide ctomies, bilateral sphenoidotomies, bilateral partial middle turbinate resections.Patient complained of pain and pressure.On (b)(6) 1999 patient presented for follow-up on her 9 weeks status post endoscopic sinus surgery.On (b)(6) 1999 patient presented for follow-up on her 9 weeks status post septoplasty, bilateral maxillary antrostomies, bilateral ethmoid ectomies, bilateral sphenoidotomies and bilateral partial middle turbinate resections.She complained of occasional frontal headache, maxillary and facial pain and pressure.On (b)(6) 1999 patient presented for follow-up on her 9 weeks status post endoscopic sinus surgery and complained of some frontal pressure and lightheadedness with associated nausea, blurred vision.On (b)(6) 1999 patient presented for an office visit and stated that she continues to have mid frontal headaches and occasional lightheadedness.Impressions: right maxillary mucosal thickening.On (b)(6) 1999 patient presented for an office visit and stated that her headache is still persistent but she is no longer having lighthea dedness.On (b)(6) 1999 patient presented for an office visit, and stated that she has continued to have headaches since her endoscopic sinus surgery ((b)(6) 1999).On (b)(6) 2000 patient presented with sinus problems, frontal headache, and facial pain.Impression of physical examination: cephalgia of mixed type but does not appear to be sinus related today; tmj capsulitis.On (b)(6) 2000 the patient was presented for office visit fro re-evaluation of her sinuses.She has also reported frontal headaches, facial pain and pressure.Impressions: cephalgia; tmj capsulitis.On (b)(6) 2003 patient presented with the complaint of sore throat, cough, chest tightness.Diagnosis: acute pharyngitis, acute bronchitis.On (b)(6) 2003 the patient was presented for office visit.Impressions: acute pharyngitis; acute bronchitis; cough; nasal deviation; post nasal drainage.On (b)(6) 2004 patient presented for follow up.Impression of physical examination: acute sinusitis- unspecified; nasoseptal deviation; cough (b)(6) 2004 patient presented with the complaint of mid face pressure, bloody mucous when blowing nose, hoarseness, nausea.On (b)(6) 2004 patient underwent allergy testing.Conclusion: patient was found allergic to the following food items: soy, beef and shrimp.On (b)(6) 2004 patient presented with the chief complaint of headache.On (b)(6) 2004 patient presented with the complaint of pain behind both eyes <(>&<)> center of forehead.Impression: chronic sinusitis; nasoseptal deviation on (b)(6) 2004 patient presented for follow up.Impression of physical examination: chronic sinusitis involving left sphenoid, bilateral anterior ethmoid and bilateral maxillary sinuses.On (b)(6) 2004 patient got admitted in hospital for undergoing endoscopic procedures.Preoperative diagnosis: chronic sinusitis involving the left sphenoid, bilateral ethmoid, and bilateral maxillary sinuses.Operative procedure: endoscopic bilateral sinus explorations with a right frontal drill out; revision endoscopic bilateral maxillary antrostomies; revision endoscopic bilateral anterior ethmoidectomies; endoscopic revision bilateral sphenoidotomies; endoscopic partial left middle turbinate resection; nasoendoscopy.Postoperative diagnoses: bilateral anterior ethmoid polyps; bilateral frontal sinus occlusion; bilateral sphenoid stenosis; recirculation phenomenon bilateral maxillary sinuses; hypertrophic left middle turbinate.No intra-operative complications were reported.On (b)(6) 2004 patient presented for follow up.Impression of physical examination: postop visit s/p bilateral frontal exploration with right frontal drill-out revision, bilateral maxillary antrostomies, bilateral total intranasal ethmoidectomies, bilateral sphenoidotomies, and partial left middle turbinate resection on (b)(6) 2004 overall doing well.On (b)(6) 2004 patient presented for follow up and underwent nasal endoscopy.Impression of physical examination: post-op edema; cephalgia secondary to #1.On (b)(6) 2004 the patient was presented for office visit with sinuses feeling.On (b)(6) 2004 patient presented for follow up and underwent ¿nasal endoscopy: mild crusting and mild edema right frontal nasal recess, all open.¿ impression of physical examination: postop edema right frontal sinus.On (b)(6) 2004 patient presented for follow up.Impression: post-op edema right nasofrontal recess; chronic cephalgia.On (b)(6) 2005 patient presented for follow up.Impression: acute left maxillary, left etlm1oid, and bilateral frontal sinusitis; allergic rhinitis; cough secondary to #1.The patient also underwent ct facial area.Impressions: there are post-surgical changes with mucosal disease noted in the frontal sinuses and remaining anterior ethmoid sinuses.On (b)(6) 2005 patient presented for follow up.Impression: chronic sinusitis; chronic cephalgia (b)(6) 2005 the patient presented with the diagnoses of purulent drainage and frontal sinusitis.Impression: eczema, external auditory canals; chronic cephalgia; chronic frontal sinusitis (b)(6) 2005 patient presented for follow up.Impression: chronic frontal sinusitis (last culture and sensitivity showed (b)(6)); nasoseptal deviation; chronic cephalgia (b)(6) 2005 the patient was presented for office visit.Review: severe headache, epistaxis.Diagnosis: chronic sinusitis.On (b)(6) 2005 patient presented for follow up.Impression: chronic sinusitis -recent (b)(6); chronic cephalgia (b)(6) 2005, (b)(6) 2006 patient presented for an office visit with chief complaint of sinusitis.Impression: chronic sinusitis; chronic cephalgia; allergic rhinitis; cough (b)(6) 2005 the patient presented for follow up on low back pain and complained of sinus pressure <(>&<)> headache.Diagnoses: low back pain; chronic sinusitis.On (b)(6) 2005 patient presented for follow up.Impression: chronic cephalgia; nasoseptal eviation; allergic rhinitis.On (b)(6) 2006 the patient was presented for office visit with headaches.Diagnosis: acute sinusitis, chronic cephalgia, cough and allergic rhinitis.On (b)(6) 2006 the patient underwent ct sinuses.Impression: findings in the right frontal sinus and also both maxillary and left sphenoid sinus consistent for chronic sinusitis.On (b)(6) 2006 the patient was presented for office visit for medication refill.On (b)(6) 2006 the patient was presented for office visit with epistaxis and headache.Diagnosis: chronic sinusitis, chronic cephalgia, cough and allergic rhinitis.On (b)(6) 2006 patient having history of chronic sinusitis and headache underwent ct sinuses.Impression: findings in the right frontal sinus and also both maxillary and left sphenoid sinus consistent for chronic sinusitis.On (b)(6) 2006 patient called and complained of headache, and was diagnosed with chronic frontal sinusitis.On (b)(6) 2006 patient presented with chief complaint of recurrent sinusitis.On (b)(6) 2006 the patient was presented for office visit.Impressions: chronic right frontal sinusitis; bilateral mild nasofrontal recess edema; all sinuses open and clear; chronic cephalgia; allergic rhinitis; turbinate hypertrophy.On (b)(6) 2006 the patient was presented for office visit.Impressions: chronic cephalgia; chronic sinusitis; alergic rhinitis; nasopetal deviation; turbinate hypertrophy.On (b)(6) 2006 patient presented for follow-up, and underwent nasal endoscopy.Impression: chronic cephalgia--possibly rebound headaches from analgesics; chronic sinusitis-improved; allergic rhinitis; nasoseptal deviation; turbinate hypertrophy (b)(6) 2007 patient presented for follow-up.Impression: left nasal ulceration; right nasal initation; columellar abrasion; nasoseptal deviation; allergic rhinitis; chronic cephalgia (b)(6) 2007 the patient was presented for office visit for follow up.Impressions: left nasal ulceration; right nasal irritation; columellar abrasion; nasopetal deviation; allergic rhinitis; chronic cephalgia.On (b)(6) 2009 patient presented with the complaint of depression.On (b)(6) 2009 patient presented complaining attention problems.On (b)(6) 2009 the patient presented with complaints of snoring, tiredness and fatigue.Impression: mild obstructive sleep apnea.On (b)(6) 2010 the patient presented for follow up.On (b)(6) 2010 patient underwent spectral doppler <(>&<)> color flow doppler study.Summary: ef about 45% with mild to moderate mr.On (b)(6) 2012 the patient presented for follow up on opiate dependence.She had had recent nasal congestion, sore throat and persistent cough.Objective exam revealed nasomucosal bogginess, lymphoid follicles, posterior oropharynx, scattered rhonchi and wheezing in the chest.Assessment: opiate dependence, on medication assisted treatment; asthmatic bronchitis; anxiety/depression.On (b)(6) 2013 patient presented for follow up for multiple medical problems.Assessment: opiate dependence on medication assisted treatment; anxiety/depression, stable; facial abrasions due fall no serious injury.On (b)(6) 2013, (b)(6) 2014 patient presented for follow up for multiple medical problems.Assessment: opiate dependence on medication assisted treatment.On (b)(6) 2013 patient presented for follow up for multiple medical problems.Assessment: opiate dependence; hx of back surgery with chronic back pain; hx of depression, stable on current medications; exacerbation of pain.On (b)(6) 2014 patient presented for follow up.Assessment: chronic neck and back pain secondary to advanced degenerative joint and disc disease.On (b)(6) 2014 patient presented for evaluation of opiate dependence with medication assisted treatment and also her depression.Assessment: opiate dependence; medication assisted treatment; co-morbid cervicalgia; co-morbid depression.On (b)(6) 2015 patient presented for routine f/u on chronic medical conditions with complaints of hypertension and depression.Patients ros (review of system) revealed: fatigue, nasal drainage, sinus pressure, chronic constipation and gerd, anxiety, depression, chronic back pain.Patient was also assessed with bipolar disorder, unspecified, attention deficit disorder of childhood with hyperactivity, vitamin d deficiency, iron deficiency anemia, obstructive sleep apnea syndrome, nontoxic uninodular goiter.On (b)(6) 2015 patient presented to establish care for her bp, gerd and gastritis.On (b)(6) 2015 patient presented with complaints of mild headache right now.Tmj and back pain.On (b)(6) 2015 patient presented follow up on htn/adhd/gerd, <(>&<)> rx review/refill.On (b)(6) 2015 patient presented with chief complaint of temporomandibular joint disorders, and stated that her pain has progressively worsened in the last 3 months.Patient¿s review of systems showed: muscle aches and arthralgias/joint pain.On (b)(6) 2014 patient presented for evaluation of opiate dependence with medication assisted treatment and also her depression.Assessment: opiate dependence; medication assisted treatment.On (b)(6) 2015 the patient also underwent a review of musculoskeletal systems.Impressions: joint pain, joint swelling, muscle pain and pain in jaw or tongue while chewing.Patient also underwent review of neurological and psychiatric systems.Impressions: headaches, numbness or tingling of arms or legs and weakness in extremities, depression and problems with sleep.On (b)(6) 2015 patient presented for 3 month follow up on htn/adhd/gerd, <(>&<)> rx review/refill.
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Event Description
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It was reported that on an unknown date: patient presented for visit.Review of systems: constitutional: fever/sweats, fatigue, loss of appetite, weight change.Neurological: headaches musculoskeletal: joint pain, muscle pain and weakness.Other: depression, anxiety (b)(6) 2016 patient present for 6 month follow up on ¿gerd, htn, bipolar¿, ¿rx¿ review /refill and lab orders.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on (b)(6) 2009 the patient underwent complete x-ray of right shoulder, result was negative.On (b)(6) 2010: the patient presented for an office visit for an evaluation regarding neck pain and headaches.On (b)(6) 2010: the patient presented for follow-up.On (b)(6) 2011: the patient presented for an office visit with chief complaint of low back pain.
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Search Alerts/Recalls
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