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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
Ossification (1428); Bruise/Contusion (1754); Chest Pain (1776); Congestive Heart Failure (1783); Dyspnea (1816); Edema (1820); Headache (1880); High Blood Pressure/ Hypertension (1908); Nerve Damage (1979); Pain (1994); Peripheral Vascular Disease (2002); Weakness (2145); Injury (2348); Depression (2361)
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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 posterior lateral interbody fusion and a posterolateral fusion surgery at l2-s1 where rhbmp-2/acs was placed in the disc space and the lateral gutters.The patient's post-operative period has been marked by pain and weakness in her legs.The patient continues to experience pain that radiates into her lower extremities.She suffers from ectopic bone growth, gastrointestinal complications, and nerve injury.
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Manufacturer Narrative
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(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.
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Event Description
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It was reported that (b)(6) 2007: patient underwent ct of head without contrast due to trauma.(b)(6) 2007: patient underwent myocardial pere spect multiple due to chest pain.(b)(6) 2007: patient presented with headache and for evaluation of stroke.Patient underwent chest x-ray.(b)(6) 2008: patient underwent x-ray of left hand due to injury.(b)(6) 2008: patient underwent left ankle x-ray due to left ankle pain status post trauma.Patient also underwent x-ray of left hip due to left hip pain status post trauma.(b)(6) 2008: patient underwent x-ray of cervical spine due to pain.Patient underwent left ankle x-ray due to trauma and pain.(b)(6) 2013: patient presented for follow up with pain located in her lower back area radiating down to the left lower extremity.Ct scan of lumbosacral spine revealed posterior fixation from l2 to s1 as noted by pedicle screws and cage insertion, laminectomy defect is noted.There is no evidence of loosening or fracture of screws.Assessment: post-lami syndrome, lumbar; sacroiliac joint dysfunction; radiculopathy- thoracic/lumbar.(b)(6) 2013: patient presented for follow up with pain located in her lower back area radiating down to the left lower extremity.Ct scan of lumbosacral spine revealed posterior fixation from l2 to s1 as noted by pedicle screws and cage insertion, laminectomy defect is noted.There is no evidence of loosening or fracture of screws.Patient reported her medications were not working well and she woke up in the middle of the night in ¿too much pain¿.Assessment: post-lami syndrome, lumbar; sacroiliac joint dysfunction; radiculopathy- thoracic/lumbar.(b)(6) 2013, (b)(6) 2014, (b)(6) 2015: patient presented for follow up with pain located in her lower back area radiating down to the left lower extremity.Ct scan of lumbosacral spine revealed posterior fixation from l2 to s1 as noted by pedicle screws and cage insertion, laminectomy defect is noted.There is no evidence of loosening or fracture of screws.Assessment: post-lami syndrome, lumbar; sacroiliac joint dysfunction; radiculopathy- thoracic/lumbar; carpal tunnel syndrome.(b)(6) 2014: patient presented for follow up with pain located in her lower back area radiating down to the left lower extremity.Patient also reported severe muscle spasms as well as pain to her cervical and lumbar spines.The pain radiated to her bilateral upper and lower extremities as well.Ct scan of lumbosacral spine revealed posterior fixation from l2 to s1 as noted by pedicle screws and cage insertion, laminectomy defect is noted.There is no evidence of loosening or fracture of screws.Assessment: post-lami syndrome, lumbar; sacroiliac joint dysfunction; radiculopathy- thoracic/lumbar; carpal tunnel syndrome.(b)(6) 2014: patient presented for evaluation of diabetic foot concerns.Patient also developed a painful area to the end of her right 3rd toe.Patient also had some increasing pain to the ball of her right foot.Her toenails grew in thickened and deformed manner.Nails rubbed in shoes causing pain and affecting her ability to walk.Patient developed painful callus that had developed to her right heel.(b)(6) 2014: patient underwent us arterial ankle/branchial index due to the indications of toe ulcer, neuropathy and diabetes.(b)(6) 2014: patient presented for the problem of ¿dfc¿.Patient¿s nail continued to grow in a thick and deformed manner and rubbed in shoes, calluses had recurred.Assessment: 1.Type i diabetes; neuropathy.2.Painful mycotic toenails.3.Preulcerative tylomas.4.History of ulcer (in remission) distal hammered right 3rd toe.(b)(6) 2015: patient presented for the problem of ¿dfc¿.Patient felt that her left hip was raising up and had pain to that area.Patient complained of painful thickened deformed toenails to both feet and calluses.Assessment: 1.Type i diabetes; neuropathy.2.Painful mycotic toenails.3.Preulcerative tylomas.4.Left hip pain with lld.(b)(6) 2015: patient presented with the problems of ¿dfc¿.Patient¿s nail continued to grow in a thick and deformed manner and rubbed in shoes, calluses had recurred.Patient ambulated minimally using a cane.There was decreased epicritic sensation to both feet.(b)(6) 2006 the patient underwent bilateral lower extremity arterial duplex study due to diabetes, hypertension and peripheral vascular disease.(b)(6) 2006 the patient underwent bone mineral density measurement of lumbar spine and hip.(b)(6) 2006 the patient underwent x-rays of the left hand.(b)(6) 2007 the patient underwent x-rays of the left foot due to trauma and bruising.(b)(6) 2007: the patient underwent x-rays of the chest due to syncope.(b)(6) 2009 the patient underwent bilateral baseline screening mammography.(b)(6) 2009 the gynecological cytology report was negative for intraepithelial lesion or malignancy.(b)(6) 2009 the patient underwent x-rays of the chest due to hypertension and diabetes mellitus.(b)(6) 2009 the patient underwent bilateral lower extremity arterial duplex study due to diabetes, weak pulse and on medications.(b)(6) 2009 the patient presented for a follow up for acute renal failure.The patient was having occasional head aches and nausea.(b)(6) 2010 the patient presented for a nephrology evaluation.(b)(6) 2011, (b)(6) 2012 the patient presented for follow up for ckd.Assessments: 1.Ckd, stage iii (moderate) 2.Diabetes with renal manifestations, type ii or unspecified type, not stated as uncontrolled 3.Essential hypertension.(b)(6) 2012 the patient presented for follow up for ckd with mild distress.The patient had tenderness over the paravertebral area on the mid dorsal to the lumbar area.Assessments: 1.Ckd, stage iii (moderate) 2.Diabetes with renal manifestations, type ii or unspecified type, not stated as uncontrolled 3.Essential hypertension.(b)(6) 2012 the patient presented for follow up for multiple comorbidities including dm, depression and anxiety, hypertension, and chronic lower back pain sec.To djd s/p multiple back surgeries).Assessment: dmii wo cmp nt st uncntr; benign hypertension; lumbago; routine medical exam.(b)(6) 2012 the patient presented for follow up for diabetes mellitus and admitted to symptoms of hypoglycemia.Assessment: diabetes mellitus without mention of complication; benign hypertension (b)(6) 2013 the patient presented due to cough.The patient described the cough as productive (of yellow sputum).It occurs occasionally.Assessment: cough.(b)(6) 2013 the patient presented with back pain, vaginal bleeding and left shoulder pain.Assessment: diabetes mellitus; post menopausal bleeding.(b)(6) 2013 the patient presented for follow up to discuss test results and for meds refill.Trans vaginal ultrasound results showed thickened endometrium.Assessment: post menopausal bleeding; anxiety.(b)(6) 2013 the patient presented for d<(>&<)>c consult.(b)(6) 2013 the patient presented for follow up on bp medication, and diabetic diet.Assessment: chronic pain; anxiety; depression; panic disorder; bipolar; (b)(6) 2013 the patient presented for surgical clearance for d<(>&<)>c and hysteroscopy.Assessment: dmii wo cmp nt st uncntr; benign hypertension; post menopausal bleeding; anxiety.The patient underwent electrocardiogram.(b)(6) 2013 the patient presented for diabetic eye exam.Findings: there was no evidence of iris neovascularization in either eye.Intraocular tensions measured normal at 15 mmhg in the right eye and 14 mmhg in the left eye.A dilated fundus evaluation showed 1+ nuclear sclerotic cataracts in both eyes.Cup-to-disc ratios were 0.25 in both eyes with healthy rim tissue, clear macula, and flat and intact peripheral retinal tissue for 360 degrees in both eyes.A careful evaluation of the posterior pole revealed no evidence of any diabetic retinopathy in either eye.(b)(6) 2013 the patient presented with the pre op diagnosis of post menopausal bleeding.The patient underwent pr biopsy of the uterus lining; hysteroscopy with dilatation and curettage.No patient complications were noted.(b)(6) 2013, patient presented for follow up for medication review.The patient presented with bipolar chronic pain, organic brain syndrome.(b)(6) 2013 patient presented for follow up with pain located in her lower back area.The patient described the pain as an ache, deep and stabbing.Assessment: dmii wo cmp nt st uncntr; lumbago.(b)(6) 2013 the patient presented with a history of post menopausal bleeding and underwent ultrasound study of the trans vaginal and pelvis.(b)(6) 2013 the patient presented with chronic pain, sadness, mood swings, and constipation.She also had gyn issues.Assessment: post menopausal bleeding; thickened endometrium (b)(6) 2013 the patient presented with vaginal bleeding.The patient described it as spotting.Assessment: post menopausal bleeding (b)(6) 2013 the patient presented for a post operative visit and she was status post dilation and curettage.(b)(6) 2013 the patient presented with back pain and diabetes.Associated symptoms include sensory neuropathy.The patient is now experiencing bilateral numbness and tingling.Assessment: diabetes mellitus without mention of complication; benign hypertension; lumbago.(b)(6) 2014 the patient presented for surgical clearance, medication refills and diabetes.Assessment: dmii wo cmp nt st uncntr; benign hypertension; lumbago; depression; carpal tunnel syndrome.(b)(6) 2014, the patient presented with chronic pain syndrome.Diagnoses: bipolar affective disorder, depressed, moderate degree; other specified nonpsychotic mental disorders following organic brain damage; panic disorder without agoraphobia; posttraumatic stress disorder; other pain disorders related to psychological factors.(b)(6) 2014 the patient in (b)(6) 2013 underwent d and c, she was noted to have simple and complex hyperplasia without atypia.She is having some intermittent bleeding.(b)(6) 2014 the patient presented for a follow up due to fainting.Assessment: syncope; hypotension.(b)(6) 2014 the patient presented for a follow up due to hypertension.Assessment: anxiety; benign hypertension; depressive disorder; chronic -pain associated with significant psychosocial dysfunction (b)(6) 2014 the patient presented for a follow up due to diabetes, hypertension, hyperlipidemia and pain.Assessment: dmii wo cmp nt st uncntr; benign hypertension; post menopausal bleeding.(b)(6) 2015 the patient presented for a follow up for diabetes, pain, medication refill and cough.The patient described the cough as productive (of green sputum).Associated symptoms include cough, heartburn, nasal congestion, post-nasal drainage and sore throat.Assessment: diabetes mellitus without mention of complication; benign essential hypertension; cough; back ache; (b)(6) 2015 the patient presented for a follow up for diabetes, lab results and medication refill.Assessment: depression; post menopausal bleeding; hyperlipidemia; vitamin d deficiency; diabetes; acute kidney injury.(b)(6) 2015.Patient presented for follow up for medication review.Diagnoses: bipolar affective disorder, depressed, moderate degree; other specified nonpsychotic mental disorders following organic brain damage; panic disorder without agoraphobia; posttraumatic stress disorder; other pain disorders related to psychological factors.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).
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Event Description
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Per medical records, it was reported that patient was implanted with k2m peek anterior biomechanical cage; stryker screws; stryker blockers; stryker max rad rods apart from rh-bmp2.Patient reported that degenerative disk disease from l2-s1; spondylolisthesis of l2-l3; herniated nucleus pulposus l3-l4, l4-l5; lumbar spinal stenosis; left lower extremity radiculopathy causing persistent back pain that sometimes interfered in daily activities led to her rhbmp-2 treatment.Patient reported following complications that resulted from her rhbmp-2 treatment: neuroforaminal narrowing, difficulty breathing; difficulty speaking; difficulty swallowing; gastrointestinal problems; nerve injury; osteoarthritis; constant pain in back that radiates to legs and feet; pain in arms and right hand; localized edema; foot drop; need to use a cane to get around; mental anguish; depression; unexplained bone growth.Patient is no longer able to participate in physical activities.
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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) 2009, the patient presented with neck pain, bilateral arm pain, back pain and bilateral leg pain.Diagnosis: lateral listhesis of l3 on l4 towards the right.Loss of lumbar lordosis.Possible grad i spondylolisthesis of l4 on l5.Grade i spondylolisthesis of l3 on l4.On (b)(6) 2009, the patient underwent mri of the lumbar spine due to lower back pain extending to the left leg.Impressions: degenerative spondylosis, lumbar spine, and facet osteoarthritis.L2-3: mild loss of disc height and t2 signal compatible with disc desiccation.Mild diffuse annular disc bulge abuts the thecal sac.Bilateral facet hypertrophic change present.No evidence of central canal stenosis.Neural foramina and exiting nerve roots are unremarkable.L3-4: loss of disc height and hydration compatible with disc desiccation.Vacuum disc phenomenon.Diffuse disc bulge with, mild ventral indentation on the decal sac which measures 4mm in ap dimension, with left lateral extension.Bilateral facet hypertrophic change present.No evidence of central canal stenosis.Disc material extends into the neural foramina and abuts the exiting l3 nerve root.Right neural foramina are patent.L4-5: loss of disc height and hydration compatible with disc desiccation.Vacuum disc phenomenon.Diffuse circumferential disc bulge slightly eccentric to the left, with an ap dimension of approximately 4-5 mm.Ventral indentation on the thecal sac.Bilateral facet hypertrophic change present, left greater than r.No evidence of central canal stenosis.Neural foramina are patent.L5-s1: loss of disc he ightxxx and hydration compatible with disc desiccation.Vacuum disc phenomenon.Diffuse disc bulge, eccentric to the right, which abuts the thecal sac, measuring approximately 2-3 mm in ap dimension.Bilateral facet hypertrophic change present, with fluid within the facet joints.No central canal stenosis demonstrated.Disc material abuts the undersurface of the exiting nerve roots, right greater than left.On 08 jun 2009, the patient presented with episodes of blacking out.Diagnosis: possible spondylolisthesis of l2 and l3.Spondylolisthesis of l3 and l4.Lateral listhesis of l3 on l4 towards the right.Degenerative disc disease at l34.Disc herniation at l34 and l45.Vacuum disc phenomenon at l34, l45 and l5s1.Loss of lumbar lordosis.Possible grade i spondylolisthesis of l4 on l5.On (b)(6) 2009: the patient presented for cardiac exam and underwent 2-d echocardiogram sonography for cardiac clearance.Impression: diastolic filling demonstrated a impaired relaxation pattern.The right atrium was mildly dilated.The right ventricular cavity was mildly dilated.The aortic valve was mildly sclerotic.Mild pulmonary hypertension.On (b)(6) 2009: the patient presented for diabetes management.Impression: type 2 diabetes mellitus.Syncopal episode with unknown etiology.Rule out peripheral vascular disease with decreased doralis pedis pulse bilaterally.On (b)(6) 2009, the patient presented with the following pre-op diagnosis: degenerative lumbar disc, acquired spondylolisthesis.The patient underwent spinal fusion c instrumentation procedure.The patient underwent x ray of frontal chest due to line/ tube placement and the history of hypoxia.Impression: no significant change.The patient also presented with x ray of frontal chest for tube placement with history of endotracheal tube placement and difficulty in breathing.Impression: cardiomegaly and at least moderate edema or chf.Endotracheal tube is in good position.Right central venous catheter with distal tip probably in area of the distal superior vena cava.There is limitation due to leftward rotation.No pneumothorax.The patient also underwent x ray of left spine due to port film3 and film2 lat left spine.Impressions: please see report.The patient also underwent x ray of left spine due to port lat left spine film1.Impressions: film labeled as number 1 demonstrating localizer needle posterior to the expected location of l2- l3.On the same day, the patient had to undergo x-ray of chest frontal, again, due to difficulty of hypoxia.Impression: no sign ificantxxx change.The patient presented with preoperative diagnosis of degenerative disk disease from l2 through s1.Spondylolisthesis of l2-l3 and l3-l4.Herniated nucleus pulposus l3-l4, l4-l5.Lumbar spinal stenosis.Left lower extremity radiculopathy.The patient underwent the following procedures.Decompressive laminectomy from l2 to s1.Posterolateral fusion from l2 through s1.Posterior interbody fusion at l2-l3, l3-l4, l4-l5 and l5-s1.Use of pedicle screw instrumentation system from l2 to s1 with use of stryker xia iii pedicle screw instrumentation system from l2-s1.Insertion of anterior biomechanical devices x4.Use of k2m peek anterior biomechanical cages: one cage placed at l2-3, one cage placed at l3-4, one cage placed at l4-5, one cage placed at l5-s1.Use of local autograft.Use of bone morphogenic protein.Use of somatosensory evoked potential electromyogram (ssep/emg) image monitoring.Use of microscope.The patient was taken to the operating room and a midline incision from l2-s1 was made.Standard anatomic landmarks were used to place pedicle screws bilaterally from l2 to s1 with the use of stryker xia iii pedicle screw instrumentation system.A high speed drill was used to perform a decompressive laminectomy at l2-3 and local bone was collected for interbody and posterolateral fusion.Once the decompression laminectomy was completed, the thecal sac was retracted to the midline and a box annulotomy was performed followed by complete discectomy using multiple size pituitary rongeurs, endplate shavers and curettes.Once the endplates were prepared down to bleeding bone, the local bone graft along with bone morphogenic protein was packed followed by a k2m peek anterior biomechanical cage.The same was repeated at l3-4.L4-5 and l5-s1 levels.Then a ball-tipped probe to palpate the central canal, lateral recess and the foramen from l2 to s1 was used to make sure that the decompression was adequate.L2 to s1 was then decorticated posterolaterally and packed local bone graft, allograft, as well as bone morphogenic protein in the posterolateral aspect of the spine to perform posterolateral fusion.The rods wee then connected bilaterally lateral to the s1, set screws were placed along with the locking mechanism.The final tightening was then performed to secure fixation.The incision was closed and the patient was stabilized.On (b)(6) 2009, the patient underwent x ray of frontal chest due to respiratory distress.Impressions: perhaps minimal improvement in airspace disease.Otherwise essentially unchanged exam.On (b)(6) 2009, the patient underwent x-ray of chest frontal, due to respiratory failure.Impression: stable portable chest was slightly improved aeration.On (b)(6) 2009, the patient underwent x-ray of chest frontal, due to difficulty in breathing.Impression: no significant change.Impression: interval extubation and nasogastric tube removal.Persistent mild congestion and possible minimal effusions.On (b)(6) 2009, the patient underwent x-ray of chest frontal, due to difficulty in breathing.Impression: unchanged appearance of the chest when allowing for differences in technique.On (b)(6) 2009, the patient underwent duplex veins lower extreme bilateral examination, due to lower extremity pain.Impression: normal bilateral lower extremity venous duplex examination.There is no evidence of deep venous thrombosis.The patient also underwent duplex scan low extreme bilateral, due to lower extremity pain with left foot palpably cooler than that on the right.Impression: unremarkable bilateral lower extremity arterial assessment.The patient also underwent x-ray of chest frontal, due to difficulty of breathing and congestive heart failure.Impression: no significant change in the appearance of the chest when compared with the prior study.On (b)(6) 2009, the patient underwent x-ray of knee, due to degenerative arthritis.Impression: degenerative changes.Superficial metallic foreign body fragment.The patient also underwent x-ray of chest, due to shortness of breath and congestive heart failure.Impression: mild congestive heart failure similar to the prior study.On (b)(6) 2009, the patient underwent x-ray for frontal chest due to chest pain.Impressions: no acute process in the chest.On (b)(6) 2009, the patient underwent x-ray of chest frontal, due to infiltrate.Impression: limited exam demonstrates no obvious significant interval change.Short-term following was recommended.On (b)(6) 2009, the patient underwent x-ray of spine-ls, for spinal fusion.Impression: interval operative fixation.The patient also underwent x-ray of chest frontal, due to shortness of breath.Impression: no significant interval change.No acute process.On (b)(6) 2009, the patient underwent x-ray of spine-ls, for status post lumbar fusion.Impression: stable postsurgical findings of the lumbosacral spine.On (b)(6) 2009, the patient underwent x-ray of spine-ls, due to history of lumbar fusion and back pain.Impression: spinal fusion from l2 through s1 and unchanged from the prior study of (b)(6) 2009.On (b)(6) 2009, the patient presented with left sided leg pain.Diagnoses: status post lumbar laminectomy and fusion from l2 to s1.On (b)(6) 2009, the patient reported with complaints of elevated blood pressure readings due to incorrect method of applying the automatic cuffs of her machine.The patient was shown the correct way and her blood pressure retaken.On (b)(6) 2009, the patient presented with left hip, groin and buttock pain.Diagnoses.Status post lumbar laminectomy and fusion from l2 to s1.Left greater trochanteric bursitis.On (b)(6) 2009, the patient underwent ct scan of pelvis without contrast, due to hip pain.Impression: degenerative changes of the hips.No acute fracture or other changes are noted at this time.The patient also underwent x-rays of the left hip due to pain.Impression: no acute osseous or articular abnormality of the left hip.The patient also underwent x-rays of the pelvis.Impression: unremarkable ap pelvis with internal fixation rods in the lower lumbar spine.On (b)(6) 2009, the patient presented with hip, groin and buttock pain.Diagnoses: status post lumbar laminectomy and fusion l2 to s1.Left greater trochanteric bursitis.On (b)(6) 2009, the patient visited for refilling the medications with no other concerns or complaints.On (b)(6) 2010, the patient presented stating elevated blood pressure and left side hip pain.The patient was examined and medicines prescribed.On (b)(6) 2010, the patient presented with back pain with radiation down the left leg.Diagnoses.Status post lumbar laminectomy and fusion from l2 to s1.Left greater trochanteric bursitis.The patient also came to discuss her bedwetting at night stating no problem during the day and also the blood pressure fluctuations.Patient needed script for new glucometer.On (b)(6) 2010, the patient underwent ct scan of ls spine without contrast, due to disc degeneration.The test indicated at l1-l2: the disc appears normal, with no obvious protrusion.At l2-l3: interpedicular screws are identified within the vertebral body of l2, which appear in adequate position.At l3-l4: interpedicular screws are identified within the vertebral body of l3, which appear in adequate position.At l4-l5: interpedicular screws are identified within the vertebral body of l4, which appear in adequate position.Impressions: postsurgical changes with adequate metallic fixations devices and good bony bridging appreciated.Possible neuroforaminal narrowing at the l3- l4 level on the left.Otherwise as detailed, with suboptimal canal evaluation due to metallic artifact.On (b)(6) 2010: the patient underwent ultrasound of the urinary bladder due to indications of diabetes, incontinence at night, hypertension.Impression: no significant postvoid residual volume.The patient also underwent ultrasound of the retroperitoneum for the same indications.Summary: normal bilateral renal ultrasound evaluation.Non-diagnostic attempted ultrasound of the abdominal aorta.On (b)(6) 2010, the patient presented for complete physical examination for annual screening.On (b)(6) 2010, the patient presented with back pain and left leg pain which had exacerbated with certain movements.Diagnoses: status post lumbar fusion from l2 to s1.On (b)(6) 2010, the patient presented with low back pain which occasionally radiated into the left leg.Diagnoses: status post lumbar laminectomy and fusion from l2 to s1.Possible delayed union at l23 and l5s1.On (b)(6) 2010, the patient came for refill of medications and the follow-up was done.On (b)(6) 2010, the patient presented with closed head injury and unspecified state of consciousness due to a fall.The patient also underwent ct scan of cervical spine without contrast due to possible fracture and history of synoscope and falling.Impression: no fracture.Degenerative changes.On (b)(6) 2011, the patient underwent us retroperitoneal complete examination due to renal mass.Impressions: no shadowing stone or hydronephrosis.If there is clinical concern for renal mass, ct with contrast utilizing renal protocol was recommended for further evaluation.On (b)(6) 2011, the patient underwent ct scan for cervical spine without contrast due to visual disturbances in the radiological report.Impressions: no acute fracture or misalignment.Multilevel hypertrophic cervical spondylotic changes with bony spur formation from c4 through c7.On (b)(6) 2011, the patient underwent mri scan of the lumbar spine, due to lower back pain extending into the left leg.Impression: degenerative spondylosis, lumbar spine, and facet osteoarthritis.L2-3: mild loss of disc height and t2 signal compatible with disc desiccation.Mild diffuse annular disc bulge which abuts the thecal ac.Bilateral facet hypertrophic change present.No evidence of central canal stenosis.Neural foramina and existing nerve roots are unremarkable.L3-4: loss of disc height and hydration compatible with disc desiccation.Vacuum disc phenomenon.Diffuse disc bulge with mild ventral indentation on the thecal sac which measures 4 mm in ap dimension, with left lateral extension.Bilateral facet hypertrophic change present.No evidence of central canal stenosis.Disc material extends into neural foramina and abuts the existing l3 nerve root.Right neural foramen is patent.L4-5: loss of disc height and hydration compatible with disc desiccation.Vacuum disc phenomenon.Diffuse circumferential disc bulge slightly eccentric to the left, with an ap dimension of approximately 4-5 mm.Ventral indentation on the thecal sac.Bilateral facet hypertrophic change present, left greater than r.No evidence of central canal stenosis.Neural foramina are patent.L5-s1: loss of disc height and hydration compatible with disc desiccation.Vacuum disc phenomenon.Diffuse disc bulge, eccentric to the right, which abuts the thecal sac, measuring approximately 2-3 mm in ap dimension.Bilateral facet hypertrophic change present, with fluid wi thin the facet joints.No central canal stenosis demonstrated.Disc material abuts the undersurface of the existing nerve roots, right greater than left.On (b)(6) 2012, the patient underwent us retroperitoneal complete aorta/ lvc/ kidneys examination due to chronic kidney disease, back pain, hypertension and abnormal blood work.Impressions: no evidence of hydronephrosis or renal calculi.Secondary to a heterogeneous echogenicity of the kidneys, further evaluation with mri or ct scan may be beneficial.
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Event Description
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It was reported that on, (b)(6) 2008: per radiology inventory record the patient underwent x-rays for chest.On (b)(6) 2009 the patient was presented for office visit in which he was diagnosed with: lateral listhesis of l3 on l4 towards the right.Loss of lumbar lordosis.Possible grade i spondylolisthesis of l4 on l5.Grade i spondylolisthesis of l3 on l4.On (b)(6) 2009: per radiology inventory record the patient underwent x-ray for ls spine.On (b)(6) 2009 the patient underwent mra of the brain.No complications were reported.The patient also underwent mra of the neck.Impressions: no evidence of significant stenosis of the common carotid arteries bilaterally or of the right proximal internal carotid artery.Suboptimal evaluation of the proximal left internal carotid artery secondary to motion artifact and technical difficulties.Suggest correlation with cta examination for further evaluation.Dominant right vertebral artery.She underwent mri of the brain.Impressions: few periventricular hyperintensities, without evidence of mass effect, nonspecific finding.Differential diagnosis includes microvascular disease, demyelinating process, vasculitis.A 1.5-cm cystic lesion in the pituitary.Findings may represent an adenoma or rathke's cleft cyst.Evaluation is limited.Recommend repeat examination with dedicated images of the pituitary and iv contrast.Mass may be the cause of patient's complaint of blurred vision (b)(6) 2009 per radiology inventory record the patient underwent x-ray for chest.Impressions: interval extubation and nasogastric tube removal.Persistent mild congestion and possible minimal effusion.On (b)(6) 2010 per radiology inventory record the patient underwent x-ray for chest and ct scan of the head.On (b)(6) 2010 per radiology inventory record the patient underwent duplex carotid art bilateral studies and a ct scan for chest.On (b)(6) 2012 per radiology inventory record the patient underwent duplex veins studies.On (b)(6) 2013 per radiology inventory record the patient underwent us pelvis complete and us transvaginal studies.On (b)(6) 2013 per radiology inventory record the patient underwent x-ray for abdomen.On (b)(6) 2013 per radiology inventory record the patient underwent x-ray for chest and ct scan of the head.On (b)(6) 2013 per radiology inventory record the patient underwent mri for ls spine and ct scan for ls spine.Impressions: posterior fixation from l2 to si is noted by pedicle screws and cage insertion.Larninectomy defect is noted.On (b)(6) 2013 the patient was presented for office visit.The patient underwent mri for lumbar spine whose impressions were posterior fixation of l2, l3, 1l4, l5 and 52 is noted by pedicle screws.Localized fluid collection is noted posterior to spin al canal measuring 1.2.Cm in ap and 8.3 cm in length from l2 to l5.Diffuse mild soft tissue edema is noted in posterior paraspinal muscle and soft tissue.The patient also underwent mri of the head.After clinical examination impressions were: severe arthritis of the knee.Back pain.On (b)(6) 2013 per radiology inventory record the patient underwent ct scans for cervical spine and thoracic spine.On (b)(6) 2013 per radiology inventory record the patient underwent x-rays for right wrist, right complete hand, left hip, chest and also underwent ct scan lumbar spine.On (b)(6) 2013 the patient was presented for consultation and medication review.Diagnosis: bipolar affective disorder; nonpsychotic mental disorders following organic brain damage; panic disorder without agoraphobia; post-traumatic stress disorder; pain disorders.On (b)(6) 2014 the patient was presented for office visit for consultation and medication review.Diagnosis: bipolar affective disorder; nonpsychotic mental disorders following organic brain damage; panic disorder without agoraphobia; post-traumatic stress disorder; pain disorders.On (b)(6) 2014 the patient was presented for office visit for consultation and medication review.Diagnosis: bipolar affective disorder; nonpsychotic mental disorders following organic brain damage; panic disorder without agoraphobia; post-traumatic stress disorder; pain disorders.
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