| Model Number 54840006540 |
| Device Problem
Fracture (1260)
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| Patient Problems
Pain (1994); Swelling/ Edema (4577)
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| Event Date 09/10/2018 |
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Event Type
Injury
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Manufacturer Narrative
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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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The information was received from the consumer via a company representative for solera screw regarding a spinal therapy.It was reported that the solera screw was broken after the surgery.On (b)(6) 2018, the plaintiff had an ls-sl spinal fusion surgery at (b)(6) hospital.This procedure involved the implantation of a rod and screws.The screws are identified as solera non -cannulated mas 6.5 mm by 40mm and 6.5 mm by 45mm screws.Initially the patient did well and his back pain was much improved.Thereafter, the patient condition deteriorated and he had an increase in his back pain with pain radiating into his right foot.On (b)(6) 2019, x-rays showed that the pedicle screws in the sacrum had fractured bilaterally.Surgeon concluded that the hardware had failed.As a result, the hoped for fusion at l5-s1 had also failed.Surgeon has recommended another surgery to remove and replace the hardware.During this time the patient condition has continued to worsen.He has had a significant increase in pain.His spine is unstable.Between the time the pedicle screws were implanted and the time the screws fractured and broke, the patient was following all doctor's orders and instructions and had experienced no physical trauma or other event which could have caused the failure.The patient with his diagnosis of lumbar stenosis with neurogenic claudication and corresponding symptoms, was a foreseeable consumer of the subject screws.There was no further complication reported.
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Event Description
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The information was received from the consumer via a company representative for solera screw regarding a spinal therapy.It was reported that the solera screw was broken after the surgery.On (b)(6), 2018, the plaintiff had an ls-sl spinal fusion surgery at bon secours st.Francis hospital.This procedure involved the implantation of a rod and screws.The screws are identified as solera non -cannulated mas 6.5 mm by 40mm and 6.5 mm by 45mm screws.Initially the patient did well and his back pain was much improved.Thereafter, the patient condition deteriorated and he had an increase in his back pain with pain radiating into his right foot.On (b)(6), 2019, x-rays showed that the pedicle screws in the sacrum had fractured bilaterally.Surgeon concluded that the hardware had failed.As a result, the hoped for fusion at l5-s1 had also failed.Surgeon has recommended another surgery to remove and replace the hardware.During this time the patient condition has continued to worsen.He has had a significant increase in pain.His spine is unstable.Between the time the pedicle screws were implanted and the time the screws fractured and broke, the patient was following all doctor's orders and instructions and had experienced no physical trauma or other event which could have caused the failure.The patient with his diagnosis of lumbar stenosis with neurogenic claudication and corresponding symptoms, was a foreseeable consumer of the subject screws.There was no further complication reported.Additional information received states that: history/comorbidities: surgical history; ¿ hernia repair ¿ back spine surgery ¿ lumabar l5-s1 fusion/ dr.(b)(6) ¿ (b)(6) /2018 past medical history: ¿ arthritis ¿ anxiety ¿ chronic bronchitis ¿ high blood pressure ¿ migraines ¿ covid 19 virus infection ¿ covid 19 ruled out by laboratory testing ¿ headache ¿ history of syncope ¿ hypertension (htn) ¿ palpitations ¿ shortness of breath ¿ sinus congestion ¿ dyslipidemia ¿ htn (hypertension), benign moderate episode of recurrent major depressive disorder.Social history: ¿ tobacco smoking status: never smoker ¿ medical power of attorney: n ¿ advance directive: n ¿ hand dominance: right ¿ marital status: married ¿ are currently employed: y ¿ occupation: therapeutic asst family history: ¿ father ¿ asthma, hypercholesterolemia, diabetes mellitus.¿ paternal grandmother - asthma, hypercholesterolemia, diabetes mellitus it was reported that: on (b)(6) 2014: the patient was a 24-year-old caucasian/ white male who presents for evaluation of sore throat, headache and diffuse myalgias which began approximately 3 days ago and described as currently moderate in severity, symptoms specifically denied include: neck stiffness, nausea, vomiting, photophobia, and mental status changes including lethargy or hypersomnolence.He has not been treated for this episode of illness as of this visit.On (b)(6) 2015: patient came for consultant visit to discuss meds result.He needs changes to the medication.He also complaint of the following: migrane ha¿s and lbp.On (b)(6) 2015: patient came for consultant visit to discuss meds result.He does not need a change in medications.He has no additional complaints.On (b)(6) 2015: patient came for consultant visit to discuss symptom¿s result.He needs changes to the medication.He also complaints of the following: ¿i need a physical and a god check up c/o nocturia, tenesmus, ha¿s almost every day¿ ¿i need to go to an ophthalm¿.On (b)(6) 2015: patient came for consultant visit to discuss bloodwork labs result.He needs changes to the medication.He also complaints of the following: ha¿s in the back of my neck , ¿lbp, scheduled for epidural¿, ¿i think my ha¿s are related to my back pain¿.On (b)(6) 2017: the patient was present with right knee pain.The problem has been present for 4 weeks.The symptoms have been moderate.The following associated symptoms are noted: edema.The following alleviating factors are noted: motrin otc help.The following aggravating factors are noted: standing, walking is uncomfortable.Previous treatments have included: none.No diagnostic studies have been performed.Started after jumping and landed on both feet, denies any left knee pain.On (b)(6) 2017: the patient had ct angiography chest w + w/o contrast.Findings: thyroid ¿ normal.Chest wall: normal.No axillary adenopathy is noted.Thoracic aorta: the thoracic aorta is normal in caliber without evidence of dissection.There is no suggestion of intramural hematoma.Pulmonary vascular bed: no focal filling defects are seen in the pulmonary vascular bed to suggest pulmonary emboli.The pulmonary artery is normal in caliber.Heart: the cardiac silhouette in normal in size and configuration.Left to right ventricular ratio is normal.No pericardial effusion was identified.Hila and mediastinum: minimal residual thymic tissue is seen in the anterior mediastinum.No mediastinal adenopathy is identified.Ni hilar adenopathy is identified.The esophagus is unremarkable.Lung fields: the lungs are clear without pulmonary consolidation or pulmonary edema.Pleural: no pleural effusion or pneumothorax is identified.Osseous structures: no aggressive osseous lesions are identified.Upper abdomen: limited images of the upper abdomen demonstrates no gross abnormality.Impression: 1.No evidence of pulmonary emboli.2.Normal thoracic aorta without evidence of dissection.3.Contrast enhanced ct of the chest otherwise with in the limits of normal.On (b)(6) 2017: patient came to discuss emergency department results.He needs changes to the medication.He also complains of the following: panic attacks and anxiety, he went to the emergency room with a history of chest pain had extensive workup including cta of the chest or lower pulmonary embolism and rule out coronary syndrome, today he realized that it was a panic attack what prompted him to go to the emergency room, he is under a lot of stress working full time and going to school full time.On (b)(6) 2018: the patient had ct head or brain w/o contrast.Findings: no hemorrhage mass effect or extra-axial fluid collection is apparent.No ventricular dilatation is evident.No acute bony abnormality is demonstrated, and the visualized sinuses are clear.Impression: no acute intracranial abnormality.On (b)(6) 2018: patient came for follow up er visit.He reports headaches and dizzy spells, high blood pressure.He reports that his bp was 190/120 when he was admitted into the er.He reports his bp home readings have been 140/100.He reports headaches that began 1 month ago.The headache occur daily and last for 10 to 45 minutes.They tend to be moderate in intensity and have an aching and throbbing quality, accompanied by nausea or photophobia.The patient has not identified any alleviating factors.He denies abdominal pain, bruising easily, chest discomfort, chills, constipation, coughing, decreased libido, diarrhea, difficulty swallowing, difficulty walking, dyspnea, ear discomfort, facial pain, fatigue, feeling depressed, fever, hematuria, hemoptysis, low back pain, lower extremity edema, malaise, nasal congestion,nausea, neck pain, oral ulcers, orthopnea, palpitations, paresthesia¿s, paroxysmal nocturnal dyspnea, poor appetite, recent head injuries, rectal bleeding, reflux, skin lesions, stress incontinence, syncope, throat pain, transient loss of neurologic function, tremor, urinary tract symptoms, visual difficulties, weakness, weight gain, weight loss and wheezing.The patient states he has been complaint with taking the medications as directed.The patient has undergone interval lab studies and tests that have been reviewed.The results are detailed in the report.Today he is here for follow up.He sis still having some episodes of dizziness.He denies any further syncope episodes.He is checking his blood pressure home and still been elevated prior to this episode that he was confused for a while after that.Today is also still complaining of some headaches.He is not taking any medications at this time.On (b)(6) 2018: patient came for consultation visit for evaluation of syncope.Patient here to establish care after a syncopal episode which occurred at work without warning.He was worked up in the er and had a negative work up.He was on meds for his cholesterol at one point, but off more recently.The patient¿s blood pressure is controlled, and he takes meds for his blood pressure.The patient denies symptoms of dyspnea with exertion, lower extremity edema, orthopnea, paroxysmal nocturnal syspnea, nocturia, exertional chest pain, non- exertional chest pain, claudication, dizziness.On (b)(6) 2018: patient came for evaluation of disequilibrium.Impression: disequilibrium without vertigo, etiology is uncertain but have a low suspicion for any peripheral vestibular disorder.On (b)(6) 2018: the patient came for follow up visit for evaluation of blood pressure.He was found to have an elevated blood pressure x 2 on a previous visit: (b)(6) 2018.Since the previous visit, he has been checking his blood pressure at home.The patient¿s blood pressure has ranged from 130/70 to 140/80.The patient has no current symptoms.He is currently taking the following medications: buspirone 10 mg oral tablet, meloxicam 15 mg oral tablet, sertraline 100 mg oral tablet, vasotec 2.5 mg oral tablet, ventolin hfa 90mcg/actuation inhalation hfa aerosol inhaler, and xanax 0.5mg oral tablet.He is not having any significant side effects from the medication.His most current bmi is 2978 kg/m² ((b)(6) 2018).Other current pertinent problem includes no problem.On (b)(6) 2019: patient came for follow up visit for hypertension.He reports no c/o.He denies other concern and his blood pressure has been fairly controlled on the patient¿s current medication.He does not record blood pressure at home.The patient states he has been complaint with taking her medications as directed but has been having difficulty complying with the recommended levels of diet and exercise.Sine your last visit, have you had any hospitalizations: no sine your last visit, have you been seen at an er: no sine your last visit, have you been seen at any specialist¿s office: no sine your last visit, have you any labs and/or imaging completed: no on (b)(6) 2020: the patient came for telehealth visit.Chief complaint: positive for covid 19.Associated symptoms: cough, shortness of breath, dyspnea on exertion and fatigue.Symptoms have been present for days.Symptoms are described as severe.He reports his whole family has been found positive for covid 19.On (b)(6) 2020: the patient came for telehealth visit.Chief complaint: palpitations.Associated symptoms: patient reports experiencing hard palpitations like arrythmia for the past few weeks.He states the palpitations have become frequent with time and are occurring a lot at night.He feels like his heart skips for few seconds.He reports his palpitations are intermittently associated with chest pain.He denies any recent syncope but has history of syncope from 3 years ago.Symptoms have been present for weeks.Symptoms are described as moderate.Sine your last visit, have you had any hospitalizations: no sine your last visit, have you been seen at an er: no sine your last visit, have you been seen at any specialist¿s office: no sine your last visit, have you any labs and/or imaging completed: no on (b)(6) 2020: the patient presents for blood draw.Blood draw was performed in the medial cubital vein of the right arm with a 22-gauge straight needle.It took 1 attempt to obtain specimen.The patient tolerated the procedure well and a coban bandage was used to protect the wound area.On (b)(6) 2020: the patient came for telehealth visit.Chief complaint: lab results and medication refill.Associated symptoms: none.He requests refill of zoloft.The fasting lipid panel was notable for marginally elevated triglycerides at 163.The kidney function test, thyroid function test were within normal limits.Sine your last visit, have you had any hospitalizations: no sine your last visit, have you been seen at an er: no sine your last visit, have you been seen at any specialist¿s office: no sine your last visit, have you any labs and/or imaging completed: yes on (b)(6) 2021: the patient came for follow up visit for hypertension.The patient went to urgent care yesterday with high blood pressure.They did an ekg which was unremarkable.The patient has been having high blood pressure throughout last week.He admits feeling anxious.He complains of palpitations and numbness and tingling in right arm.He admits to some chest discomfort.His blood pressure has been poorly controlled on the patient¿s current medication.The patient states he has been complaint with taking her medication as directed but has been having difficulty complying with the recommended levels of diet and exercise.Sine your last visit, have you had any hospitalizations: no sine your last visit, have you been seen at an er: no sine your last visit, have you been seen at any specialist¿s office: yes provide name, date and reason for visit: urgent care yesterday with high blood pressure and palpitations.Sine your last visit, have you any labs and/or imaging completed: no.On (b)(6) 2021: the patient presents for blood draw.Blood draw was performed in the medial cubital vein of the left arm with a 22-gauge straight needle.It took 1 attempt to obtain specimen.The patient tolerated the procedure well and a coban bandage was used to protect the wound area.On (b)(6) 2021: according to hcp¿s opinion to a reasonable degree of medical certainty that the patient¿s current symptoms are related to their described injury.New medication was prescribed today.Proper use of medication was discussed, and precaution given (mobic flexeril).As the patient had a significant pre-existing condition including spondylolisthesis and previous surgery per dr steichen would recommend follow up evaluation with him for possible complications from previous surgical intervention.He would most likely require an update mri scan of the lumbar spine to evaluate the lumbar radiculopathy that has recurred after the work injury.Lower back pain: m54.5: low back pain.Xr, lumbar spine view (x-ray, lumbar spine): ap & lateral.Back care and preventing injuries: care instructions.Lumbar spondylolisthesis.History of lumbar fusion: xr, lumbar spine: view (x-ray, lumbar spine): ap & lateral review of x-ray, lumbar spine taken on (b)(6) 2020 at low country orthopedics & sports med (n charleston) shows: radiographic findings: no fracture and no dislocation.Grade 1 spondylolisthesis l5-s1 with instrumentation in place.Evidence of fracture pedicle screw.On (b)(6) 2021: the patient came for follow up for hypertension and lab results.His blood pressure has been well controlled on the patient¿s current medications.He takes home blood pressure readings and the readings have been in the 120-140/80-100 range.The patient states he has been complaint with taking her medications as directed but has been having difficulty complying with the recommended levels of diet and exercise.Sine your last visit, have you had any hospitalizations: no sine your last visit, have you been seen at an er: no sine your last visit, have you been seen at any specialist¿s office: no sine your last visit, have you any labs and/or imaging completed: yes.
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Manufacturer Narrative
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Additional information updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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The information was received from the consumer via a company representative for solera screw regarding a spinal therapy.It was reported that the solera screw was broken after the surgery.On (b)(6) 2018, the plaintiff had an ls-sl spinal fusion surgery at bon secours (b)(6) hospital.This procedure involved the implantation of a rod and screws.The screws are identified as solera non -cannulated mas 6.5 mm by 40mm and 6.5 mm by 45mm screws.Initially the patient did well and his back pain was much improved.Thereafter, the patient condition deteriorated and he had an increase in his back pain with pain radiating into his right foot.On (b)(6), 2019, x-rays showed that the pedicle screws in the sacrum had fractured bilaterally.Surgeon concluded that the hardware had failed.As a result, the hoped for fusion at l5-s1 had also failed.Surgeon has recommended another surgery to remove and replace the hardware.During this time the patient condition has continued to worsen.He has had a significant increase in pain.His spine is unstable.Between the time the pedicle screws were implanted and the time the screws fractured and broke, the patient was following all doctor's orders and instructions and had experienced no physical trauma or other event which could have caused the failure.The patient with his diagnosis of lumbar stenosis with neurogenic claudication and corresponding symptoms, was a foreseeable consumer of the subject screws.There was no further complication reported.Additional information received states that: implant date(s): (b)(6) -2018 patient demographics: gender- female, initials (b)(6), age - 36, dob - (b)(6) 1982, weight ¿ 230 lbs, race: caucasian/ white; ethnicity: not hispanic or latino history/comorbidities: surgical history; hernia repair, back spine surgery ¿ lumabar l5-s1 fusion/ dr.(b)(6)¿ (b)(6) 2018 past medical history: arthritis, anxiety, chronic bronchitis, high blood pressure, migraines, covid 19 virus infection, covid 19 ruled out by laboratory testing, headache, history of syncope, hypertension (htn), palpitations, shortness of breath, sinus congestion, dyslipidemia, htn (hypertension), benign moderate episode of recurrent major depressive disorder.Social history: tobacco smoking status: never smoker, medical power of attorney: n, advance directive: n, hand dominance: right, marital status: married, are currently employed: y, occupation: therapeutic asst family history: father ¿ asthma, hypercholesterolemia, diabetes mellitus.Paternal grandmother - asthma, hypercholesterolemia, diabetes mellitus it was reported that: on (b)(6) 2014: the patient was a 24-year-old caucasian/ white male who presents for evaluation of sore throat, headache and diffuse myalgias which began approximately 3 days ago and described as currently moderate in severity, symptoms specifically denied include: neck stiffness, nausea, vomiting, photophobia, and mental status changes including lethargy or hypersomnolence.He has not been treated for this episode of illness as of this visit.On (b)(6) 2015: patient came for consultant visit to discuss meds result.He needs changes to the medication.He also complaint of the following: migrane ha¿s and lbp.On (b)(6) 2015: patient came for consultant visit to discuss meds result.He does not need a change in medications.He has no additional complaints.On (b)(6) 2015: findings/ impression- bilateral pars defects are again noted at ls.With flexion, there is 8 mm anterolisthesis of ls on s1.There is no significant change on extension.Other levels the lumbar spine is within normal limits.Findings/impression: 3 views of the lumbosacral spine used.Patient again status post posterior lumbar fusion l5-s1 for grade 1 ante rolisthesis.Disc spaces well maintained.No acute compression deformity seen.Si joint symmetric, soft tissue unremarkable.On (b)(6) 2015: patient came for consultant visit to discuss symptom¿s result.He needs changes to the medication.He also complaints of the following: ¿i need a physical and a god check up c/o nocturia, tenesmus, ha¿s almost every day¿ ¿i need to go to an ophthalm¿.On (b)(6) 2015: patient came for consultant visit to discuss bloodwork labs result.He needs changes to the medication.He also complaints of the following: ha¿s in the back of my neck , ¿lbp, scheduled for epidural¿, ¿i think my ha¿s are related to my back pain¿.On (b)(6) 2017: the patient was present with right knee pain.The problem has been present for 4 weeks.The symptoms have been moderate.The following associated symptoms are noted: edema.The following alleviating factors are noted: motrin otc help.The following aggravating factors are noted: standing, walking is uncomfortable.Previous treatments have included: none.No diagnostic studies have been performed.Started after jumping and landed on both feet, denies any left knee pain.On (b)(6) 2017: the patient had ct angiography chest w + w/o contrast.Findings: thyroid ¿ normal.Chest wall: normal.No axillary adenopathy is noted.Thoracic aorta: the thoracic aorta is normal in caliber without evidence of dissection.There is no suggestion of intramural hematoma.Pulmonary vascular bed: no focal filling defects are seen in the pulmonary vascular bed to suggest pulmonary emboli.The pulmonary artery is normal in caliber.Heart: the cardiac silhouette in normal in size and configuration.Left to right ventricular ratio is normal.No pericardial effusion was identified.Hila and mediastinum: minimal residual thymic tissue is seen in the anterior mediastinum.No mediastinal adenopathy is identified.Ni hilar adenopathy is identified.The esophagus is unremarkable.Lung fields: the lungs are clear without pulmonary consolidation or pulmonary edema.Pleural: no pleural effusion or pneumothorax is identified.Osseous structures: no aggressive osseous lesions are identified.Upper abdomen: limited images of the upper abdomen demonstrates no gross abnormality.Impression: 1.No evidence of pulmonary emboli.2.Normal thoracic aorta without evidence of dissection.3.Contrast enhanced ct of the chest otherwise with in the limits of normal.On (b)(6) 2017: patient came to discuss emergency department results.He needs changes to the medication.He also complains of the following: panic attacks and anxiety, he went to the emergency room with a history of chest pain had extensive workup including cta of the chest or lower pulmonary embolism and rule out coronary syndrome, today he realized that it was a panic attack what prompted him to go to the emergency room, he is under a lot of stress working full time and going to school full time.On (b)(6) 2018: the patient had ct head or brain w/o contrast.Findings: no hemorrhage mass effect or extra-axial fluid collection is apparent.No ventricular dilatation is evident.No acute bony abnormality is demonstrated, and the visualized sinuses are clear.Impression: no acute intracranial abnormality.On (b)(6) 2018: patient came for follow up er visit.He reports headaches and dizzy spells, high blood pressure.He reports that his bp was 190/120 when he was admitted into the er.He reports his bp home readings have been 140/100.He reports headaches that began 1 month ago.The headache occurs daily and last for 10 to 45 minutes.They tend to be moderate in intensity and have an aching and throbbing quality, accompanied by nausea or photophobia.The patient has not identified any alleviating factors.He denies abdominal pain, bruising easily, chest discomfort, chills, constipation, coughing, decreased libido, diarrhea, difficulty swallowing, difficulty walking, dyspnea, ear discomfort, facial pain, fatigue, feeling depressed, fever, hematuria, hemoptysis, low back pain, lower extremity edema, malaise, nasal congestion,nausea, neck pain, oral ulcers, orthopnea, palpitations, paresthesia¿s, paroxysmal nocturnal dyspnea, poor appetite, recent head injuries, rectal bleeding, reflux, skin lesions, stress incontinence, syncope, throat pain, transient loss of neurologic function, tremor, urinary tract symptoms, visual difficulties, weakness, weight gain, weight loss and wheezing.The patient states he has been complaint with taking the medications as directed.The patient has undergone interval lab studies and tests that have been reviewed.The results are detailed in the report.Today he is here for follow up.He sis still having some episodes of dizziness.He denies any further syncope episodes.He is checking his blood pressure home and still been elevated prior to this episode that he was confused for a while after that.Today is also still complaining of some headaches.He is not taking any medications at this time.On (b)(6) 2018: patient came for consultation visit for evaluation of syncope.Patient here to establish care after a syncopal episode which occurred at work without warning.He was worked up in the er and had a negative work up.He was on meds for his cholesterol at one point, but off more recently.The patient¿s blood pressure is controlled, and he takes meds for his blood pressure.The patient denies symptoms of dyspnea with exertion, lower extremity edema, orthopnea, paroxysmal nocturnal syspnea, nocturia, exertional chest pain, non- exertional chest pain, claudication, dizziness.On (b)(6) 2018: patient came for evaluation of disequilibrium.Impression: disequilibrium without vertigo, etiology is uncertain but have a low suspicion for any peripheral vestibular disorder.On (b)(6) 2018: report: x-ray spine lumbosacral 2 or 3 view back pain.Indication: twisting injury while playing golf.Comparison: (b)(6) 2015 findings: there are 5 lumbar vertebral bodies.Vertebral body height is grossly preserved.Grade 1 anterolisthesis at l5-s1, grossly like the prior radiographs.Chronic appearing underlying bilateral pars defects at this level, grossly similar.Moderate constipation.Si joints and sacral struts are grossly within normal limits.Impression: no acute vertebral body height loss.On (b)(6) 2018: mri-lumbar spine without contrast.Finding: alignment and bony structures.Chronic bilateral l5 pars defects with 5mm grade 1 anterolisthesis.L5-s1 mild anterolisthesis.Horizontal orientation of the l5-s1 neural foramen.Conus medullaris; normal signal and caliber.Findings by level: t12/l1: normal.L1/2: normal l2/3: normal.L3/4: normal.L4/5: minimal disc bulge.Mild facet hypertrophy.No stenosis.L5/s1: moderate facet hypertrophy.Shallow protrusion converts to disc bulge biforaminally.Deflection and flattening exiting l5 against pars fragments with flattening more prominent on the right and possible increased signal in the compressed nerve roots on both sides.Impression: 1.Bilateral chronic l5 pars defects withgrade 1 anterolisthesis of 5mm and draping of exiting l5 nerve roots over expos ed disc biforaminally.The nerve roots are flattened against pars fragments superiorly even in the supine position, with increased signal suggestion compression neuritis.2.No significant change since previous study.On (b)(6) 2018: report: x-ray spine lumbosacral 2 or 3 view.History: s/p lumbar fusion.Comparison: (b)(6) 2018 findings: interval bilateral l5-s1 interpedicular screw fixation with residual grade 1 anterolisthesis.Mild disc space narrowing.Underlying pars defect.Impression: l5-s1 interpedicular screw fixation.On (b)(6) 2018: finding/ impression: 3 view technique of the lumbosacral spine used.Patient again status post posterior lumber fusion l5-s1 for grade 1 anterolisthesis.Disc space is well maintained.No acute compression deformity seen.Si joints symmetric.Soft tissue unremarkable.Images are obtained through the chest with iv contrast without adverse reaction.Ct scanning was performed using radiation dose reduction technique.Finding: small hiatal hernia is present.The liver, spleen, adrenal glands, gallbladder and pancreas appear normal.The kidney appears normal.Moderately large colonic stool volume noted compatible with constipation.There is some questionable stranding in the fat around the left colon, not a firm finding but possible representative of colitis.Appendix negative.Small volume gas within the urinary bladder, nonspecific and without apparent etiology by ct.There is evidence of prior lumbosacral transpedicular rod and screw fixation with posterior decompression and probable pars interarticularis defects with anterolisthesis l5 compared to s1.Impression: small hiatal hernia.Suspicion of constipation.Borderline stranding in the fat around the left colon, not a definite finding but possibly representative of mild colitis.Nonspecific trace of gas in the urinary bladder.On (b)(6) 2018: the patient came for follow up visit for evaluation of blood pressure.He was found to have an elevated blood pressure x 2 on a previous visit: (b)(6) 2018.Since the previous visit, he has been checking his blood pressure at home.The patient¿s blood pressure has ranged from 130/70 to 140/80.The patient has no current symptoms.He is currently taking the following medications: buspirone 10 mg oral tablet, meloxicam 15 mg oral tablet, sertraline 100 mg oral tablet, vasotec 2.5 mg oral tablet, ventolin hfa 90mcg/actuation inhalation hfa aerosol inhaler, and xanax 0.5mg oral tablet.He is not having any significant side effects from the medication.His most current bmi is 2978 kg/m² ((b)(6) 2018).Other current pertinent problem includes no problem.On (b)(6) 2019: lumbar vertebral body heights are maintained.There is no evidence of aggressive osseous lesion.At l1-l2 and l2-l3 disc height are well maintained.At l3-l4 and l4-l5 disc height is reasonably well maintained.There is very minimal grade 1 retrolisthesis, which is not significantly change in flexion and extension.At l5-s1, previous bilateral rod and pedicle screw fixation.No specific adverse features are noted about the hardware.Underlying pars interarticularis defects.Impression: 1.At l5-s1, prior bilateral rod and pedicel screw fixation.No specific adverse features are noted about the hardware.Findings suggest slight interval loss of disc height.Underlying pars interarticularis defects and prominent grade 1 anterolisthesis again demonstrated.2.No definite change in alignment at any lumbar level with flexion and extension.On (b)(6) 2019: vertebrae: lumbar vertebral body heights are maintained.No aggressive osseous lesion is demonstrated.Alignment: there is grade 1 anterolisthesis l5-s1, with underlying bilateral pars interarticularis defects.There is minimal grade 1 retrolisthesis at l4-l5.L1-l2: disc height is well maintained.No stenosis.L2-l3: disc height is well maintained.No stenosis.L3-l4: disc height is well maintained.No stenosis.L4-l5: disc height is well maintained.Mild narrowing of the neural foramina.L5-s1: previous laminectomy, bilateral rod and pedicle screw fixation.There are bilateral pars interarticularis defects with grade 1 anterolisthesis, superior disc uncovering/ mild bulge and slight osteophyte formation.Severe bilateral neural foraminal stenosis.Impression: 1.At l5-s1, no adverse features are noted about the bilateral rod and pedicle screw fixation hardware.No evidence of osseous union.Underlying l5 pars interarticularis defects again noted.There remains severe bilateral neural foraminal stenosis secondary to grade 1 anterolisthesis with superior disc uncovering/ mild bulge and mild loss of disc height.2.At l4-l5, there is mild narrowing of the neural foramina.On 02-december-2019: patient came for follow up visit for hypertension.He reports no c/o.He denies other concern and his blood pressure has been fairly controlled on the patient¿s current medication.He does not record blood pressure at home.The patient states he has been complaint with taking her medications as directed but has been having difficulty complying with the recommended levels of diet and exercise.Sine your last visit, have you had any hospitalizations: no sine your last visit, have you been seen at an er: no sine your last visit, have you been seen at any specialist¿s office: no sine your last visit, have you any labs and/or imaging completed: no on (b)(6) 2020: finding: there are 5 lumbar type vertebral bodies.Minimal retrolisthesis l2-3 no l3-4 as before.L4-5 and l5-s1 demonstrate bilateral rod and pedicle screw fixation.Although difficult to visualize, there is apparent left s1 pedicle screw fracture and bilateral l5 screw fracture described previously on ct lumbar spine and lumbosacral spine.L5-s1 demonstrate underlying pars interarticularis defects.There is prominent loss of disc height.There is a grade 1 anterolisthesis l5-s1 similar to prior.Limited range of motion on the flexion-extension views.No instability appreciated.No fracture.Impression: grade 1 anterolisthesis is stable.On (b)(6) 2020: the patient came for telehealth visit.Chief complaint: positive for covid 19.Associated symptoms: cough, shortness of breath, dyspnea on exertion and fatigue.Symptoms have been present for days.Symptoms are described as severe.He reports his whole family has been found positive for covid 19.On (b)(6) 2020: the patient came for telehealth visit.Chief complaint: palpitations.Associated symptoms: patient reports experiencing hard palpitations like arrythmia for the past few weeks.He states the palpitations have become frequent with time and are occurring a lot at night.He feels like his heart skips for few seconds.He reports his palpitations are intermittently associated with chest pain.He denies any recent syncope but has history of syncope from 3 years ago.Symptoms have been present for weeks.Symptoms are described as moderate.Sine your last visit, have you had any hospitalizations:no sine your last visit, have you been seen at an er: no sine your last visit, have you been seen at any specialist¿s office: no sine your last visit, have you any labs and/or imaging completed: no on (b)(6) 2020: the patient presents for blood draw.Blood draw was performed in the medial cubital vein of the right arm with a 22-gauge straight needle.It took 1 attempt to obtain specimen.The patient tolerated the procedure well and a coban bandage was used to protect the wound area.On (b)(6) 2020: the patient came for telehealth visit.Chief complaint: lab results and medication refill.Associated symptoms: none.He requests refill of zoloft.The fasting lipid panel was notable for marginally elevated triglycerides at 163.The kidney function test, thyroid function test were within normal limits.Sine your last visit, have you had any hospitalizations: no sine your last visit, have you been seen at an er: no sine your last visit, have you been seen at any specialist¿s office: no sine your last visit, have you any labs and/or imaging completed: yes on (b)(6) 2020: finding: reformatted images demonstrate preservation of lumbar vertebral body height again with grade 1 anterolisthesis of l5 on s1 where there is stable bilateral pedicle is documentation and bilateral l5 pars defect.Although there is no peri hardware lucency, the bilateral s1 pedicle screw is fractured and there is no bony bridging across the disc or facets.Slight reversal of the normal lumbar lordosis again notes with stable trace retrolisthesis of l4 on l5 as before.No acute fracture nor traumatic malalignment of the lumbar spine, include soft tissue as normal.There is no bony canal stenosis form l1 through l5.At l1-s5, minimal bulge with disc uncovering without bony canal stenosis.Stable severe bilateral foraminal stenosis.Impression: 1.Stable postsurgical changes and alignment at l5-s1 again with bilateral fracture s1 pedicle screws and severe bilateral foraminal stenosis.2.No acute fracture of the lumbar spine and no bony canal or further foraminal stenosis.On (b)(6) 2020: finding: there are 5 types of vertebral lumbar bodies.Status post revision of posterior screw and rod fixation of l5-s1 with intervertebral spacer device in place.There is mild grade 1 anterolisthesis of l5 over s1, similar to prior.No acute hardware complication.No anterior height loss or fracture line.No lytic or sclerotic lesion.Midline skin staples in place.Impression: status post revision of posterior screw and rod fixation of l5-s1 with intervertebral spacer device in place.There is mild grade 1 anterolisthesis of l5 over s1, similar to prior.No acute hardware complication.On (b)(6) 2021: finding: l5-s1 rod and screw fixation with disc spacer device.The disc spacer device projects as before.L5 pars interarticularis defects are present and there is approximately 9mm anterolisthesis l5 compared to s1which is unchanged compared to prior study.L4-5-disc height is preserved.L2-3 show minimal posterior disc space narrowing as before.Minimal facet degeneration is questioned on the right at l3-l4.There is no evidence of hardware failure or fracture.There is no malalignment skin clip has been removed.Impression: interim stability since november.On (b)(6) 2021: the patient came for follow up visit for hypertension.The patient went to urgent care yesterday with high blood pressure.They did an ekg which was unremarkable.The patient has been having high blood pressure throughout last week.He admits feeling anxious.He complains of palpitations and numbness and tingling in right arm.He admits to some chest discomfort.His blood pressure has been poorly controlled on the patient¿s current medication.The patient states he has been complaint with taking her medication as directed but has been having difficulty complying with the recommended levels of diet and exercise.Sine your last visit, have you had any hospitalizations: no sine your last visit, have you been seen at an er: no sine your last visit, have you been seen at any specialist¿s office: yes provide name, date and reason for visit: urgent care yesterday with high blood pressure and palpitations.Sine your last visit, have you any labs and/or imaging completed: no.On (b)(6)2021: the patient presents for blood draw.Blood draw was performed in the medial cubital vein of the left arm with a 22-gauge straight needle.It took 1 attempt to obtain specimen.The patient tolerated the procedure well and a coban bandage was used to protect the wound area.On (b)(6) 2021: according to hcp¿s opinion to a reasonable degree of medical certainty that the patient¿s current symptoms are related to their described injury.New medication was prescribed today.Proper use of medication was discussed, and precaution given (mobic flexeril).As the patient had a significant pre-existing condition including spondylolisthesis and previous surgery per dr steichen would recommend follow up evaluation with him for possible complications from previous surgical intervention.He would most likely require an update mri scan of the lumbar spine to evaluate the lumbar radiculopathy that has recurred after the work injury.Lower back pain: m54.5: low back pain.Xr, lumbar spine view (x-ray, lumbar spine): ap & lateral.Back care andpreventing injuries: care instructions.Lumbar spondylolisthesis.History of lumbar fusion: xr, lumbar spine: view (x-ray, lumbar spine): ap & lateral review of x-ray, lumbar spine taken on (b)(6) 2020 at low country orthopedics & sports med (n charleston) shows: radiographic findings: no fracture and no dislocation.Grade 1 spondylolisthesis l5-s1 with instrumentation in place.Evidence of fracture pedicle screw.On (b)(6) 2021: the patient came for follow up for hypertension and lab results.His blood pressure has been well controlled on the patient¿s current medications.He takes home blood pressure readings and the readings have been in the 120-140/80-100 range.The patient states he has been complaint with taking her medications as directed but has been having difficulty complying with the recommended levels of diet and exercise.Sine your last visit, have you had any hospitalizations: no sine your last visit, have you been seen at an er: no sine your last visit, have you been seen at any specialist¿s office: no sine your last visit, have you any labs and/or imaging completed: yes.
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