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| Model Number 3606290 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Neurological Deficit/Dysfunction (1982); Neuropathy (1983); Paralysis (1997); Numbness (2415); Spinal Cord Injury (2432)
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| Event Date 02/17/2020 |
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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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It was reported that intra-op, the spinal cord was hit by one of the in-situ benders.Neurological deficit was realized after this event occurred.The patient is reported to have symptoms of partial paralysis due to this event.
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Manufacturer Narrative
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The following rods were used in this procedure: model: g7753890 lot: 0646378w; udi: 00643169101357 510(k): k180851 model: g7753880 lot: 0635984w; udi: 00643169101371 510(k): k180851 model: g7753890 lot: 0646378w; udi: 00643169101357 510(k): k180851 it was mentioned whether these products malfunctioned.This mdr is being filed for notification purpose.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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Patient demographics: gender- female it was reported that on 17 feb 2020, intra-op, the patient suffered from partial paralysis.Spinal cord was hit by one of insitu benders.Neurological deficit was realized after this event.According to surgeon, cut out notch on the bender was not deep enough of a recess for the rod to fit into.It needed to be deeper like the vertex ones.
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Event Description
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Additional information was received regarding the event.The patient had medical history of anxiety, post-therapeutic neuralgia, low back pain, possible restless leg syndrome, hld, pre-diabetes, osa and fatty liver.The patient had surgical history of appendectomy 1968, total abdominal hysterectomy and bilateral salpingo-oophorectomy for fibroids and ovarian cysts 2006, partial colectomy of the sigmoid for mesenteric abscess 2013, heart cath hysterectomy lap chole on (b)(6) 2018.It was reported that the patient had lower extremity swelling and states trauma due to a neck surgery, in which the surgeon hit her spinal cord.The pain/symptoms began approximately since on (b)(6) 2020 and symptoms include numbness, swelling and tingling.The patient had an emg which showed bilateral carpal tunnel syndrome and she was started on cock-up splints.The patient had laminectomy for decompression c3, c4.Andes intralaminar laminotomy for decompression c7, t1.Posterior-lateral arthrodesis c2 through t1, segmental posterior spinal instrumentation c2-t1 and foraminotomy bilateral, c6-7 for an indication of cervical spondylitis myelopathy, ossification of posterior longitudinal ligament and intraoperative spinal cord injury.The patient underwent a barium swallow last fall, which actually showed mild dysfunction due to bulky cervical spine osteophytosis.She subsequently developed paresthesia's of her upper extremities and underwent an mri, which did show c3-4 cord gliosis.She was referred to dr.Cochran for definitive management.After medical clearance, she was admitted to (b)(6) regional on (b)(6) 2020, whereupon she underwent multilevel decompression culminating in a c2 to t1 posterior cervical fixation.Evoked potentials were lost during the procedure.She was started on bracken protocol and was admitted to the icu postoperatively.The patient was felt medically stable for discharge on (b)(6) 2020, discharged from acute care and admitted to inpatient rehabilitation on the same day.She continues to have paresthesia's of the right hand and weakness of the left lower extremity and left upper extremity.Left upper extremity motor exam has declined slightly with worsened triceps firing.Patient complaining of some joint pain as a possible rebound issue after stopping steroids.The electromyography and nerve conduction testing of patient's left upper extremity, as well as nerve conduction testing of patient's left lower extremity performed on (b)(6) 2020 showed findings consistent with: 1.Diffuse left upper extremity active denervation with intact nerve conduction evaluation, including intact left median and ulnar sensory distal latencies raising consideration of more proximal, diffuse cervical cord ventral root injuries versus less likely very proximal nerve root injuries or consideration of left brachia! plexopathy.2.Suggestion of minimal left carpal tunnel syndrome.3.Borderline low amplitude of lower extremity compound motor action potentials raising suspicion of mild axonal neuropathy.
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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.
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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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Additional information was received regarding the event.The patient weight is 210 lbs.The patient had disability of no use of left arm and partial paralysis.It was reported that in the fall of 2019, the patient went to a physician complaining about arms being asleep when woke up.They did an mri of patient's neck and found that the patient had severe stenosis in three cervical vertebrae.The physician told that it was so bad that if she were in a car wreck or shifted my neck quickly, she could end up quadriplegic.The physician decided that patient needed to have a cervical laminectomy and fusion performed.Radiological diagnosis performed on (b)(6) 2022 for labial abscess worsening since first of month, hx of a cyst, labial abscess showed that there are a few tiny foci of nonorganized fluid, soft tissue gas and inflammatory stranding involving the left paramedian labia and extending superiorly to the mons pubis, suggesting early phlegmon.However, there is no abnormal focal enhancing thick-walled fluid collection to suggest a drainable abscess.Non-contrast multiplanar multisequence mri of the cervical spine is performed.There is straightening of the cervical lordosis.The vertebral bodies are grossly maintained in height.There is trace anterolisthesis of c5 on c6.There is fusion of the c5 and c6 vertebral bodies.Postsurgical changes are noted from instrumented posterior spinal fusion from c2 through t1, and laminectomies from c3 through c6 level.There is a stable area of myelomalacia in the cord at c3-c4 level.The rest of the cord is normal in caliber and signal.No intrathecal masses or fluid collections are seen.
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Manufacturer Narrative
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Additional information: radiographic image review - mri (b)(6) 2019 multilevel degenerative changes c3-4 c4-5 with spinal stenosis c5-6 spondylolisthesis probable congenial fusion at c6-7.C7-t1 disc construction and spinal stenosis.Axial imaging screening for opll c7-t1 stenosis not as severe as on axial imaging.Mri c-spine (b)(6) 22 posterior decompression achieved c2-c6.A large area of myelomalacia is present on c4.On axial imaging this appears to affect a large portion of the l hemi cord.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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Additional information: b5 b5.Desc evt problem: contd admission date: on (b)(6)2020 reason for admission: spinal cord injury.History of present illness: ms.(b)(6) is a very pleasant 63-year-old lady, with past medical history notable for impaired fasting glucose and hypertension, who developed dysphagia several years ago.She ultimately underwent a barium swallow last fall, which actually showed mild dysfunction due to bulky cervical spine osteophytosis.She subsequently developed paresthesia¿s of her upper extremities, and underwent an mri, which did show c3-c4 cord gliosis.She was referred to dr.(b)(6) for definitive management.After medical clearance, she was admitted to (b)(6) regional on (b)(6) 2020, where upon she underwent a multilevel decompression, culminating in a c2-t1 posterior cervical fixation.Evoked potentials were lost during the procedure.Shew-as started on bracken protocol and admitted to the icu postoperatively.Her strength improved.She was stabilized and transferred to the floor.Her strength subsequently defined, and she was restarted on iv steroids.Her strength subsequently improved again.She was seen by speech and language pathology, with recommendations of aspiration risk.She was seen by pt and ot, with recommendations of continuing service.At the time of interview, she noted persistent paresthesia¿s of the right hand, along with minimal weakness of the left lower extremity.She noted more significant weakness of the left upper extremity.No nausea, vomiting, fevers, or chills.No chest pain or shortness of breath.Past medical history: hypertension, gero, asthma, allergic rhinitis, anxiety, post herpetic neuralgia, possible restless legs syndrome, hyperlipidemia, impaired fasting glucose, obstructive sleep apnea, steatohepatitis, and hypothyroidism.Past surgical history: appendectomy, tah and bso, partial colectomy, left heart catheterization, hysterectomy, and cholecystectomy.Allergies: vicryl sutures and cipro.Physical examination - neurologic: exam reveals cranial nerves 2-12 grossly intact strength 1/5, left upper extremity, 5/5 right upper extremity, 4+/5 left lower extremity, 5/5 right lower extremity.Deep tendon reflexes are absent sensation is altered below c4 on the left, and c5 on the right plantar responses are mute bilaterally.Diagnostic studies: review of pertinent radiologic studies shows chest x-ray from february 10, with no acute finding.Ekg shows normal sinus rhythm, with sinus arrhythmia.2d echo from (b)(6) 2019, shows ef 60% to 65%, normal left ventricular systolic function, grade 2 diastolic dysfunction.Post admission physician eval: the patient presents for inpatient rehabilitation following diagnoses, as noted in the history and ph ysical.There are no medical or functional changes since the preadmission assessment.The patient has ongoing medical and functional impairments that can safely be met in the irf setting, and these needs cannot be adequately addressed in a lower level of care, as the patient requires 24hr nursing and daily medical management.The patient also has comorbidities, as noted in the history and physical, and the combination of these diagnoses and comorbidities also necessitate close medical supervision, specialized rehabilitation nursing, and skilled therapy intervention.The patient is able to participate in and benefit from an acute inpatient rehabilitation program, with anticipated measurable gains as a result ofthis program.Prior to admission, the patient was independent with all adls and mobility.Currently, the patient requires moderate assistance for both adls and mobility.There are no obvious barriers to disposition to the community following the irf admission.Date: on (b)(6) 2020 nerve conduction results: left median motor distal latency was 3.39 msec with amplitude 4.5 mv.Left median nerve conduction velocity across patient's forearm was 60.0 m/sec with amplitude 2.6 mv.Left median sensory distal latency was 3.33 msecwith amplitude 20.1 microvolts.Left median f-wave latency was 30.3 msec.Left ulnar motor distal latency was 2.19 msec with amplitude 2.6 mv.Left ulnar nerve conduction velocity across patient's forearm was 59.0 m/sec with amplitude 2.4 mv, and across the elbow was 61.0 m/sec with amplitude 2.1 mv.Left ulnar sensory distal latency was 2.71 msec with amplitude 20.7 microvolts.Left peroneal distal latency was 4.64 msec with amplitude 0.5 mv.Left peroneal nerve conduction velocity across patient's calf was 47.0 m/sec with amplitude 0.6 mv, and across the fibular head was 46.0 m/sec with amplitude 0.8 mv.Left peroneal f-wave latency was 53.1 msec.Left tibial distal latency was 3.75 msec with amplitude 0.5 mv.Left tibial motor nerve conduction velocity across patient's calf was 44.0 m/sec with amplitude 0.9 mv.Left sural distal latency was 2.24 msec with amplitude 5.1 microvolts.Electromyography: electromyography of left abductor pollicis brevis showed increased needle insertion activity, 3+ positive waves, 3+ fibrillations, 0 fasciculations with moderate to marked decreased recruitment.Left abductor digit mini mi show increased needle insertion activity, 3+ positive waves, 3+ fibrillations, 0 fasciculations with marked decreased recruitment.Left brachioradialis showed mild increased needle insertion activity, 0 fasciculations, 0 fibrillation, 0 positive waves with moderate decreased recruitment.Left biceps showed increased needle insertion activity, 2+ to 3+ positive waves, 2+ to 3+ fibrillations, 0 fasciculations with moderate to marked decreased recruitment.Left deltoid showed increased needle insertion activity, 2+ to 3+ positive waves, 2+ to 3+ fibrillations, 0 fasciculations with moderate decreased recruitment.Left triceps showed increased needle insertion activity; complex repetitive discharges with 2+ positive waves, 1+ to 2+ fibrillation, 0 fasciculations and moderate racing with decreased recruitment.Interpretation: electromyography and nerve conduction testing of patient's left upper extremity, as well as nerve conduction testing of patient's left lower extremity showed findings consistent with: 1.Diffuse left upper extremity active denervation with intact nerve conduction evaluation, including intact left median and ulnar sensory distal latencies raising consideration of more proximal, diffuse cervical cord ventral root injuries versus less likely very proximal nerve root injuries or consideration of left brachial plexopathy.2.Suggestion of minimal left carpal tunnel syndrome.3.Borderline low amplitude of lower extremity compound motor action potentials raising suspicion of mild axonal neuropathy.Date/time: on (b)(6) 2020 neuropsychology progress note: patient's chart and current medications are reviewed, and patient is seen on (b)(6)2020 and also today (90832) to address cognitive, affective and behavioral residuals of her diagnoses of left c4 and right cs asia d sci, s/p bracken protocol, and cervical myeloradiculopathy, s/p c2-t1 posterior decompression and fusion.Comorbidities include prominent anxiety symptoms which she treated pta with xanax 0.5mg prn anxiety.This medication has now been discontinued.She remains alert, 0 x 4 without cues provided, and is right dominant.Speech is fluent.Expressive and receptive language abilities appear wfl.She is mildly distractible, yet able to complete simple, personal 2¿3-part verbal commands.She is able to recall recent events on this unit today.She recalls the sequence of her earlier therapies today.She is able to describe her recent neurosurgery and feedback from her physicians.She is also able to recall her recent and remote personal and medical histories.Her cognition appears generally wfl and will continue to be closely monitored during this hospitalization.Her mood remains stable.She describes continued, mild improvements in the multiple new functional changes she has experienced following her recent neurosurgery.She denies any s/s suicidality or psychosis.She continues to be aware that she may not experience a full and complete neu ro-recovery.She tells me she has been thinking of what she will need to be able to do better prior to home discharge.Today she has been able to walk over 200 feet with her rw.She can move herself in bed to get comfortable.She still has problems putting her tops and socks on.She is pleased with her current progress, and guardedly hopeful.Her neck and upper back pain remain generally well-managed.Pain has not been a barrier to her participation in rehab therapies.She is sleeping better and is using her home cpap mask.Her otr continues to adapt devices for her to use here to allow her to operate her call light, cell phone, etc.She is working with her nurse on her bladder and bowel issues.Staff report no behavioral concerns.Date/time: on (b)(6)2020 neuropsychology progress note: patient's chart and current medications are reviewed, and patient is seen on (b)(6)2020 and also today (90832) to address cognitive, affective and behavioral residuals of her diagnoses of left c4 and right cs asia d sci, s/p bracken protocol, and cervical myeloradiculopathy, s/p c2-t1 posterior decompression and fusion.Comorbidities include prominent anxiety symptoms which she treated pta with xanax 0.5mg prn anxiety.This medication has now been discontinued.She remains alert, 0 x 4 without cues provided, and is right dominant.Speech is fluent.Expressive and receptive language abilities appear wfl.She is able to complete simple, personal 3-part verbal commands.She is able to recall recent events on this unit today.She recalls the sequence of her earlier therapies today.She is able to describe feedback from her physicians.She is also able to recall her recent and remote personal and medical histories.Her cognition appears generally wfl and will continue to be closely monitored during this hospitalization.Her mood remains stable.She describes continued, mild improvements in the multiple new functional changes she has experienced following herrecent neurosurgery.She denies any s/s clinical depression, suicidality or psychosis.She continues to be cautiously optimistic and aware that she may not experience a full and complete neuro-recovery.She continues to focus on what she will need to be able to do better prior to home discharge.Today she is to be made modified independent in her room, and she recalls she is to generally function from a wheelchair level here and when she returns home.Her neck and upper back pain remain generally well-managed.Pain has not been a barrier to her participation in rehab therapies.She is sleeping better and is using her home cpap mask.Her otr continues to adapt devices for her to use here to allow her to operate her call light, cell phone, etc.She is working with her nurse on her bladder and bowel issues.Staff report no behavioral concerns.We address her pending home discharge plans.Her son has changed out her bed at her independent living facility; she now has a twin bed once used by her mother-in-law, which is equipped more like her current hospital bed.She is aware of equipment being ordered, including a wheelchair.Concerns addressed.I have also informed patient to contact me directly should she elect to follow up with any op counseling services.Order date: on (b)(6)2020 clinical history: l knee pain findings: two views of the knee are obtained.No fracture, dislocation or bony destructive lesion is identified.No evidence for joint effusion or lip hemarthrosis.There is mild tricompartmental degenerative change.Impression: no evidence for fracture or dislocation.Mild tricompartmental degenerative change procedure date: on (b)(6)2020 clinical history: weakness post pcdf on (b)(6) 2020 technique: on a 1.5 tesla magnet noncontract multiplanar multisequence images are obtained through the cervical spine.Dedicated spine coil was utilized.Findings: no acute fracture or subluxation.Cervical vertebral body heights and alignment are stable.There is susceptibility artifact associated with posterior fusion hardware c2-t1 levels.There is postprocedural superficial soft tissue fluid signal changes c2-c3 through t1-t2 levels.C2-c3: posterior disc osteophyte formation and likely ligamentous ossification with similar findings previously.Spinal canal stenosis improved with posterior surgical decompression.C3-c4: there is severe posterior disc osteophyte formation and ligamentous ossification similar to previous exam.Spinal canal stenosis improved from previous exam with posterior decompression.There is still flattening of the spinal cord.There is focal cord t2 hyperintensity left of midline suspicious for myelomalacia.C4-c5: posterior disc osteophyte formation and ligamentous thickening similar to previous.Spinal canal stenosis improved following posterior surgical decompression.Spinal cord remains flattened.C5-c6: spinal canal stenosis improved with posterior surgical decompression.No significant foraminal narrowing.C6-c7: there is bony fusion and disc space.No significant spinal canal stenosis, neuroforaminal narrowing or focal disc herniation.C7 -t 1: posterior disc osteophyte formation and i ligamentous thickening similar to previous.Spinal canal stenosis improved surgical posterior decompression.Impression: focal spinal cord signal abnormality left of midline c3-c4 level suspicious for myelomalacia.Portions of the spinal cord c3-c4 and c4-c5 remain flattened.Levels of previously demonstrated spinal canal stenosis with interval improvement following surgical decompression.History: partial paralysis lower extremities and left arm, post-op.Reference: 3/6/2020 cervical spine mri.Findings: ap and lateral views of the cervical spine demonstrate postop changes from prior c2-t1 dorsal decompression and hardware fusion, with bilateral pedicle screws and vertically oriented posterior stabilization rods.Hardware is grossly intact and well located.There is multilevel degenerative disc disease and ventral osteophytosis, with a large bridging osteophyte extending from c4 through c6.Vertebral body heights and alignment are normal.There is no bony destruction or focal asymmetric soft tissue pathology.Impression: postop cervical spine radiographs demonstrating fusion hardware from c2 through t1.Procedure date: on (b)(6)2021 history: arthrodesis status, neck pain, trouble with full extension of neck.Reference: on (b)(6) 2020 cervical spine.Findings: ap and lateral views of the cervical spine were obtained.Stable postop changes and dorsal fusion hardware are again noted from c2 through t1.Hardware remainsintact.Multilevel degenerative disc disease and ventral flowing osteophytosis is unchanged.There is no bony destruction or malignement.Impression : stable cervical spine radio graphs.Date: on (b)(6) 2022 right knee arthroscopic partial "medial meniscectomy and chondroplasty.Preoperative diagnosis: right knee medial meniscus tear and chondromalacia.Postoperative diagnosis: right knee medial and lateral meniscus tear, chondromalacia, grade 2 3 patella, medial and lateral compartment.Procedure: right knee arthroscopy, partial medial and lateral meniscectomy, chondroplasty patellofemoral, medial and lateral compart ments.Diagnoses and all orders for this visit: acute medial meniscus tear of right knee, initial encounter: acute pain of right knee date of study: on (b)(6) 2022 history: shoulder pain.The patient is experiencing tenderness in the biceps tendon and acromioclavicular joint.Examination: mri right shoulder without contrast multisequence/multiplanar imaging was performed in routine fashion without contrast.Ac joint and coracoacromial arch: there is mild hypertrophy at the ac joint causing no significant impingement upon the underlying supraspinatus muscle/tendon.The patient has a type ii acromion with no significant decrease in the lateral acromiohumeral distance.On (b)(6) 2022 history of present illness: this is a 66-year-old female who presents with the chief complaint of pain, numbness and weakness in the right upper extremity.She reports neck pain.Pain is stabbing and burning in quality.It progressed.Activity aggravates her symptoms.She reports sleep disturbance due to pain and numbness.She reports history of cervical spinal cord injury.Past medical history: burning in the feet, high cholesterol, neck and back pain, hypertension, bladder infections.Social history: she works as a pharmacist.She is n widow.She is a smoker.She drinks three alcoholic beverages per week.She denies street drug use history.Physical examination - musculoskeletal: there is decreased active range of motion in the cervical spine and pain with active range of motion reported.There is surgical scarring, well healed and not infected.Motor: muscle strength is 5/5 in bilateral upper extremities.Deep tendon reflexes are normal in bilateral upper extremities.No hoffmann's reflex is noted.The rest of the examination is documented in the hard chart.Medical decision making: this is a patient who presents with a chief complaint of neck and arm pain and right upper extremity paresthesia¿s.This needs to be investigated, differential diagnosis would include right cervical radiculopathy, right brachial plexopathy, compression neuropathy and polyneuropathy.Electrophysiological testing is medically indicated.Emg interpretation: 1.Right cs and right c6 radiculopathy.2.Mild right median neuropathy at the wrist.2.Mild right ulnar neuropathy at the elbow.On (b)(6) 2022: patient presents with right knee ¿ pain 3 view xray of the right knee indicate minimal degenerative changes.History: susan brasel is a 65 y.O.Female here for their right knee pain.This is a new visit.The problem began in 2017.The condition is due to trauma.The current status of the condition is worse.(b)(6) describes the pain as dull.She rates the pain 6 currently.She states she is taking gabapentin and norco for her pian.She states her knee is popping on occasion.She states she is having walking pains.She states she had a spine injury in (b)(6) 2020.The patient is experiencing tenderness in the lateral joint line and medial joint line.Mri of the right knee: complex tear of the medial meniscus.Fluid deep to the medial collateral ligament.Question grade 1 sprain.T ricompartmental degenerative changes with chondromalacia most pronounced in the patellofemoral compartment.On (b)(6) 2022: 2+ view x-ray of the right shoulder indicates mild degenerative joint disease and acromioclavicular arthrosis.Numbness and tingling to right upper extremity extending to right hand.Mri right shoulder w/o contrast: normal rotator cuff complex.There is mild hypertrophy at the ac joint causing no significant impingement upon the underlying supraspinous muscle tendon.Intact biceps tendon.I see no acute bony pathology in the shoulder.There are a few tiny superolateral humeral head cysts.Their significance is doubtful.Medical treatment timeline pcp ¿ visit re: hands <(>&<)> arms going to sleep.On (b)(6) 2019 - did emg, diagnosed carpal tunnel syndrome.Swallow study ¿ showed kink in neck due to spinal bone spurs.Referred to dr (b)(6).Mri ¿ showed bone spurs in neck.Dr (b)(6) said if she were in bad accident, bone spurs would damage the spinal cord, causing quadriplegia.On (b)(6) 2020 - spine surgery causing injury.On (b)(6)2020 - admitted for inpatient rehab ¿ for rue dexterity deficit, lle weakness and severe lue weakness.On (b)(6)2020 - pt: can now go to bathroom w/walker.Walks w/o walker, with 2-person assist.Working on strength to left side, left leg stability is iffy.Right side feels tingly and asleep, but not as much as left side.Moving fingers on left hand, can sort-of grip something lightweight.Can¿t lift left arm, but if she uses right hand to lift her left, she can pick up lightweight things.On (b)(6)2020 - pcp said it may take a long time to fully recover, if she recovers.Pt worked on balance, walking <(>&<)> some exercises.Nurse set up meds for next week.(susan cannot open medicine bottles easily and cannot pick up pills individually and put them in med-minder container.) home health aide assisted w/shower.On (b)(6)2020 - pt ¿ walking easier but still unsteady, susan afraid she will fall.Left hip starts to hurt and therefore she cannot be on her feet for a long period of time.On (b)(6) 2020 - pt and ot.Tried to stretch left shoulder upward.Can¿t get it to raise above head w/o assistance.Left arm still flaccid for most part.Subluxation of left shoulder.Right shoulder sore from strain, right hand still cannot feel things¿frustrating to not be able to pick things up without looking.Major muscle spasms today, had to take extra flexeril and oxycodone.(normally takes only at bedtime.) spilled flexeril pills when opened the bottle¿frustrating to try to pick up individual tablets.Fingers on right hand don¿t work, fine motor skills are lacking.Right hand has not improved at all since surgery.On (b)(6)2020 - hand and arm exercise, stretched left shoulder¿almost got left arm to vertical above shoulder.It is tight and almost frozen due to not being able to move left arm into this position by herself.Still cannot put elbow at 90-degree angle.On (b)(6)2020 - fell and hit knee on table, fell to floor¿managed to get up by herself.Knee not bad enough to go to er.Still has muscle spasms and tingling all over body.Sometimes nerves firing (?) is extremely uncomfortable¿like having a tens unit plugged on her body and turned up to full-blast.Constant vibration that varies in intensity.Very annoying.Working on computer is a challenge¿can¿t hold mouse for any length of time because sensation in hand feels like mouse just came out of the freezer.Everything is extremely cold to the touch and painful.On (b)(6) 2020 ¿ (b)(6)2020 - two ot and 2 pt sessions.On (b)(6)2020, nurse came to set up meds for coming week and help unpack from hospital stay 3 weeks ago (couldn¿t do it on her own).Left hand swollen all week¿unsure if from fall on (b)(6) or because it hangs down most of the time when walking/standing.X-ray after fall (on 4/15) came back normal.Had to pay out-of-pocket for wheelchair tray to support left arm (insurance wouldn¿t cover).Scalded right hand (hand sort-of works but can¿t feel temperature).Left hand which is numb and useless can feel temperature.On (b)(6)2020 - (b)(6) hand still swollen, turns cyanotic if not elevated and moving.Props her arm up higher than her heart as much as possible, but this is hard because she can¿t lift her arm.Home health company will try to get order for ultrasound to rule out blood clot.Has used hydrochlorothiazide to try to keep swelling down, but it lowers bp, so pcp said discontinue unless bp goes too high.Can¿t move fingers very well due to swelling.Can¿t close her fist.Can¿t do exercises she needs to do.On (b)(6)2020 - home health still waiting on authorizations from insurance company, for continued pt and ot.On (b)(6)2020 ¿ (b)(6)2020 - home health got authorization ¿ pt and ot done on (b)(6)2020.Home health has not heard about order for ultrasound, brought compression material for arm.On (b)(6)2020 - ot/hhc requesting new insurance approval for services for another month.(pt may be finished w/treatment.) susan has showered by herself a few times, although still uneasy about this due to balance issues.Nurse still setting up meds each week¿susan still has great difficulty opening medication bottles and handling individual pills.Left hand and fingers swollen, fingers turn blue when not elevated.On (b)(6)2020 - hhc nurse comes once weekly; aide comes twice weekly; ot comes twice weekly.Discontinued pt for now.Legs are getting stronger, trying to walk more.On (b)(6)2020 - went to outpatient pt to look at hand swelling.Found out afterward that once she goes to outpatient facility for anything, home health is discontinued.Once outpatient treatment is concluded, home health can be reinstated.She needs four services¿nursing, shower aid and ot are done by home health care and lymphatic massage must be done outpatient.On (b)(6)2020 - began home health ot.On (b)(6)2020 - still cannot use deltoid muscle to raise shoulder.Has driven twice in past week.Must use right hand to cross over steering wheel to use turn signal.Left arm hangs down, neck and shoulder bear the weight and get tired.A lot easier to dictate letters and emails than to type them.On (b)(6)2020 - more pain this month than last month.Nerve function seems to be coming back¿feelsskin ¿crawling¿ and has had more spastic leg kicks at night, sometimes keeping her awake.Alternating between nsaids, opiates and muscle relaxants.Feels every vibration of any building she is in.Pcp and neurosurgeon said this is brown-sequard syndrome (with spinal cord lesion, weakness or paralysis on one side of the body and a loss of sensation on the opposite side).(b)6)2020 - started pt.Will have 20 visits over 10 weeks.On (b)(6)2020 - recent c-spine x-ray shows ¿reversal of normal cervical lordosis¿ (natural curve of neck has changed since surgery).She now has to fight to keep head and neck in upright position¿feels like there is a spring in her neck, forcing her head forward and down.On (b)(6)2020 - susan has been reading her nrh record, noting: postop day 1 notes are wrong.She could not move easily; her right arm did move, was numb and uncoordinated; legs were very weak; could not ambulate at all; no proprioception in left leg and very little in right; left arm totally flaccid; could not move fingers on left hand.On (b)(6)2020 - susan has made some improvements w/pt.Insurance authorized 12 ot visits, will probably start next week.On (b)(6)2020 - first ot visit.Will have ot w/pt following for next 2 weeks.Ot authorized for 12 visits.Pt ends at end of year.On (b)(6)2021 - started ot again.(scheduled for12 visits.) work on grip strength, finger control.After ot visits, she swims/does pool exercises she learned from previous pt.On (b)(6) 2021 - bp low, he stopped bp meds.Told her to ¿keep on doing what she¿s doing¿ otherwise.On (b)(6)2021 - finished ot, made some progress w/regard to strength.8/18/21 - unsteady short steps, though can climb stairs w/both legs; inability to raise left arm above shoulder; little grip strength in left hand; stroke-like positioning of left fingers <(>&<)> wrist; steady shaking/movement of left hand <(>&<)> lower arm that she holds w/right hand; forward positioning of left shoulder and arm in front of left thigh when she walks, rather than swinging by her side.Speech <(>&<)> swallow appear normal.She is erect side-to-side, rather than leaning left.On (b)(6)2021 - will start 9-session pt on (b)(6)2021 (for more pain, discomfort and flexibility issues).Has very painful arthritis in right knee.Will have cataract surgery in november.On (b)(6) 2021 - bad diarrhea, low bp.Ambulance to hospital, gave iv fluids, all tests normal.Maybe light food poisoning? on (b)(6) 2021 - started experiencing more numbness, pain.On (b)(6)2021 - more muscle tightness.Will ask dr love if she can increase baclofen to max dosage.(has appt w/him week of (b)(6).On (b)(6) 2022 - will do knee surgery for meniscus tear, degenerative changes w/chondromalacia (may likely be related to compensating for damaged leg/foot).On (b)(6)2022 - knee surgery.On (b)(6)2022 - susan had knee surgery¿doing pretty well.On (b)(6)2022 - for about past month, waking up w/right arm more numb than usual¿still nerve issue from spinal cord injury.Goes more numb when holding out in front of her, like grabbing top of steering wheel or while using computer.On (b)(6)2022 - started pt 3x/week, pt recommending ot.On (b)(6)2022 - pain in right shoulder ¿for a while now.¿ more numb when ¿sleeps on it wrong.¿ knots in right bicep, pt tries to massage out.Dr west will refer to neurologist to do emg to check for pinched nerve in shoulder.Pt says nerves have gotten bound up w/fascia and are irritated due to overuse of right arm to compensate for lack of use of left arm.On (b)(6)2022 - having nerve issues in bilateral upper arm muscles¿muscle knots that hurt, in constant state of contraction.Right arm feels like it¿s on fire much of the time.Pt tries to massage bicep and pectoral insertion points ¿sends me through the roof¿ when she presses on them.On (b)(6)2022 - emg ¿ dr pitman said nerve problems in arm likely caused by 3 issues: surgical neck injury, ulnar nerve in elbow and carpal tunnel.On (b)(6)2023 - right arm and hand getting worse¿whole arm feels like it¿s on fire.Tactile sensations and dexterity getting worse.On (b)(6)2023 - will start pt again, to try to keep arm stretched out.Now taking robaxin as needed, at bedtime.Still wakes up with numb arm.Sometimes numb on pinky (ulnar nerve), sometimes thumb (radial nerve).Vertebrae in neck has shifted forward or backward.Perhaps only way to straighten is chiropractic treatment¿but chiro won¿t touch her after neck surgery.On (b)(6)2023 - right arm/shoulder still hurting¿pt thinks it could be shoulder impingement.On (b)(6)2023 - mri of right wrist/elbow on 4/25/23, had to lie flat on stomach on table, with arm stretched out over her head.Since mri, unable to place right hand under arm pit, which makes it difficult to dress, etc.On (b)(6)2023 - seeing for elbow and wrist issues ¿ dr.(b)(6) is referring her to dr.(b)(6) he can give injections in the neck) on (b)(6)2023 - neck injection on (b)(6)2023 - visit w/dr.(b)(6).He wants to do another injection to try to help right elbow/wrist.(first one was at c6¿this one would be higher.) if this doesn¿t work, she will have surgery.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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Additional information was received regarding the event.The patient had surgical history of appendectomy, hysterectomy and spine surgery.Procedure date: on (b)(6)2019.Reason for exam: bone spur, ant and difficulty swallowing there is grade 1 anterolisthesis of c5 on c6.There are prominent bridging anterior endplate osteophytes at c3-c4, c4-c5, c5-c6 and c6-c7.The largest osteophytes are at c4-c5 and c5-c6.There is ossification of the posterior longitudinal ligament extending from c3 inferiorly through the c5-c6 level.There is partial fusion across the disc space at c6-c7.The vertebral bodies are otherwise normal in height and alignment.There is no evidence to suggest a marrow replacing process.There is disc space narrowing and disc desiccation throughout.The crania cervical junction is unremarkable.C2-c3: there is ossification of the posterior longitudinal ligament.There is mild bilateral facet hypertrophy.These changes combine to cause mild narrowing of the spinal canal.There is minimal bilateral neural foramen stenosis.C3-c4: there is exuberant ossification of the posterior longitudinal ligament.There is minimal bilateral facet hypertrophy.There is severe narrowing of the spinal canal with perhaps mild gliosis within the compressed cervical cord.There is mild bilateral neural foramen narrowing, right greater than left.C4-c5: there is exuberant ossification of the posterior longitudinal ligament.There is minimal bilateral facet hypertrophy.There is severe narrowing of the spinal canal without evidence to suggest cord edema, myelomalacia or gliosis.There is mild bilateral neural foramen narrowing.C5-c6: there is slight anterolisthesis of c5 on c6.There is mild to moderate ossification of the posterior longitudinal ligament.There is moderate to severe right and mild left facet hypertrophy.There is overall mild narrowing of the spinal canal.There is mild bilateral neural foramen stenosis.C6-c7: there is partial fusion across the disc space at this level.There is no evidence for disc bulge or herniation.There is mild osteophytic ridging of the vertebral bodies.There is mild bilateral facet hypertrophy, left greater than right there is no significant spinal canal or right neural foramen narrowing.There is mild narrowing of the left neural foramen.C7-t1: there is a prominent disc osteophyte versus isolated ossification of the posterior longitudinal ligament.There is mild bilateral facet hypertrophy.This combines to cause moderate to severe narrowing of the spinal canal without evidence for cord edema or myelomalacia.There is no significant neural foramen stenosis.History of present illness: initial evaluation: on (b)(6) 2020 patient reports having swelling in her l hand for approximately 2 months now.She had neck surgery in (b)(6) 2020 - she woke from surgery completely paralyzed, had to go to icu/ inpatient rehab.She was dcd home on (b)(6)2020 - had home health pt for 8 weeks, she continues to have home health ot.She has regained ability to walk but continues to have impaired sensation throughout her body.She states that her left ues and right ue are doing pretty well, but her left shoulder/ elbow/ hand continues to be weak with increased swelling noted in left hand that affects her dexterity.She has had us to rule out blood clot in left ue.Illness severity or complexity: left ue weakness due to sci.Body part/system being evaluated: left hand.Patient subjective report: patient states that she tries to elevate her left hand at night.She reports that her left-hand swelling used to fluctuate but it has stayed very swollen around the knuckles for several weeks now and affects her dexterity.Patient receiving home health ot at this time to address left ue weakness.Patient goals: manage edema in left hand.Social history: recreational activities, hobbies, and/or participation: playing cards/ dominoes.History of present illness: initial evaluation: on (b)(6) 2020 medical care prior to current episode: surgery was on (b)(6)2020, 5 weeks of inpatient rehab ending in (b)(6).Home health from (b)(6) , then again (b)(6).Patient discharged d/t meeting goals.History of present illness: patient went in for a cervical fusion and laminectomy from c2-t1 resulting in an sci injury w/ weakness in l side of the body and decreased sensation bilaterally ue>le and r>l.Referring pt to ot hand therapist for eval and treat as well.Medical diagnosis: sci s/p cervical spinal fusion/laminectomy on (b)(6) 2020.Patient subjective report: pt reports that her l shoulder feels very stiff today.Number of visits to date: 14.Summary of program to date: pt.Has been seen for progressive mobility training, balance, and progressive.Lue rom and strengthening, with both land and aquatic therapy instruction, with good progress to date and good understanding of final hep.She demonstrates improved score on lefs from 32 to 61/80 and improved quick dash from 68% to 47% impairment.Pt.'s insurance authorization has ended, and pt.No longer requires continued skilled pt services at this time.Recommendations: dic to independent hep at this time.Reference: on (b)(6) 2020 cervical spine radiographs.Findings: 3 views of the cervical spine were obtained.Stable postoperative changes and dorsal fusion hardware are again noted from c2 through t1.Hardware remains intact.There is reversal of the normal cervical lordosis, unchanged multilevel degenerative disc disease and ventral flowing osteophytosis consistent with diffuse idiopathic skeletal hyperostosis, most notable from c4 through c6.Vertebral body heights and alignment are normal.There is no fracture or bony destruction.Prevertebral soft tissues are not widened.Impression: stable cervical spine radiographs.Procedure date: on (b)(6) 2020 clinical history: spine cervical2v, spine thoracic 2v; rom loss post fusion findings: ap and lateral thoracic spine views are obtained.No acute fracture or subluxation.Thoracic vertebral bodies demonstrate normal height and alignment.Intact partially visualized postop changes and fusion hardware are observed at t1 and the cervicothoracic junction.There is multilevel degenerative disc disease and ventral flowing osteophytosis consistent with diffuse idiopathic skeletal hyperostosis.There is no vertebral body compression or bony destruction.Remaining pedicles are intact and symmetric.Impression: no acute thoracic spine findings.Chronic multilevel degenerative changes, as described.Procedure date: on (b)(6) 2020 history: arthrodesis status; neck pain, numbness in arms and fingers.2 views of the cervical spine.Findings: frontal and lateral views of the cervical spine.Posterior fusion from c2 to t1 again noted.Vertebral body height is fairly well maintained.Marked anterior bridging osteophyte again seen from c4 to c6 and moderate findings at c7/t1.There is no apparent fracture.Impression: no change.Procedure date: on (b)(6) 2020 the venous doppler test of the left upper extremity and neck area demonstrates satisfactory blood flow augmentation and lumen compression of all major veins.There is no evidence for deep or superficial venous thrombosis.Impression: normal venous study of left upper extremity and neck.Procedure date: on (b)(6)2020 the left upper extremity duplex arterial exam demonstrates satisfactory pressures and triphasic waveforms.There is no evidence for occlusive disease.Impression: normal left upper extremity duplexes arterial exam.Procedure date: on (b)(6)2020 history: arthrodesis status, left arm paralysis, neck pain.Reference: on (b)(6) 2020 cervical spine radiographs.Findings: ap and lateral views of the cervical spine were again obtained.Stable postop changes are again identified from prior c2-t1 dorsal hardware fusion.There is multilevel degenerative disc disease and ventral osteophytosis, most profound from c4 through c6.There is no fracture, compression deformity, subluxation or bony destruction.Soft tissues are otherwise unremarkable.Impression: stable cervical spine radiographs.Procedure date: on (b)(6)2020 history: partial paralysis lower extremities and left arm, post-op.Reference: on (b)(6) 2020 cervical spine mri.Findings: ap and lateral views of the cervical spine demonstrate postop changes from prior c2-t1 dorsal decompression and hardware fusion, with bilateral pedicle screws and vertically oriented posterior stabilization rods.Hardware is grossly intact and well located.There is multilevel degenerative disc disease and ventral osteophytosis, with a large bridging osteophyte extending from c4 through c6.Vertebral body heights and alignment are normal.There is no bony destruction or focal asymmetric soft tissue pathology.Impression: postop cervical spine radiographs demonstrating fusion hardware from c2 through t1.Date: on (b)(6) 2020 history of present illness: the patient is a 63-year-old female who presents today for evaluation.The patient is a very pleasant 63-year dd lady who complains of symptoms located in the lower extremity swelling.Patient states trauma due to a neck surgery, in which the surgeon hit her spinal cord.The pain/symptoms began approximately (since on (b)(6) 2020.Symptoms include numbness, swelling and tingling.Patient states the pain 1st at a level 3/10.Symptoms are exacerbated by daily activity use and forceful grip.Patient was previously treated by an internist.Previous diagnostic tests have included a duplex venous.Past treatment has included application of heat, application of ice, brace, ot, compression garment.Oral medication and physical therapy.The patient states that symptoms have impeded with previous treatment.Allergy: cipro *fluoroouinolones* (drug allergy) and allergies reconciled past medical: hypertension, thyroid condition, anxiety and problems reconciled past surgical: gallbladder surgery, hysterectomy and appendectomy.Colectomy.Date of procedure: on (b)(6) 2020 preoperative diagnosis: cervical spondylotic myelopathy, ossification of posterior longitudinal ligament.Postoperative diagnosis: cervical spondylotic myelopathy, ossification of posterior longitudinal ligament, intraoperative spinal cord injury.Procedure(s) performed: laminectomy for decompression c3, c4 and c5 intralaminar laminotomy for decompression c7, t1.Posterior-lateral arthrodesis c2 through t1.Segmental posterior spinal instrumentation c2-t1.Foraminotomy bilateral, c6-7.Operative indications: this patient is a pleasant 63-year-old pharmacist was evaluated in outpatient setting.She was found have significant spinal cord compression secondary to ossification of posterior longitudinal ligament from c3 to c5.She is also found to have significant stenosis c7-t1.She has initially sent for evaluation of swallowing difficulty secondary to significant osteophyte formation anteriorly.However, discovery of this led to physical exam revealing significant myelopathic features.We advised the patient of these findings and the need for surgical decompression given her deficits.We discussed an anterior approach versus a posterior approach elected for the latter due to the risk approaching this anteriorly.We reviewed with her the risks, benefits, and potential complications of the selected procedure as outlined in the h<(>&<)>p.After weighing her options, she elected to proceed with the above-stated procedure.Complications: intraoperative spinal cord impaction secondary to instrument malfunction.Procedure date: on (b)(6)2020 history: partial paralysis lower extremities and left arm, post-op reference: on (b)(6) 2020 cervical spine mri.Findings: af and lateral views of the cervical spine demonstrate postop changes from prior c2-tl dorsal decompression and hardware fusion1 with bilateral pedicle screws and vertically oriented posterior stabilization rods.Hardware is grossly intact and well located.There is multilevel.Degenerative disc disease and ventral osteophytosis, with alarge bridging osteophyte extending from c4 through c6.Vertebral body heights and alignment are normal.There is no bony destruction or focal asymmetric soft tissue pathology.Impression: postop cervical spine radiographs demonstrating fusion hardware from c2 through t1.Reference: on (b)(6) 2020 - cervical spine radiographs.Findings: ap and lateral views of the cervical spine were again obtained.Stable postop changes are again identified from prior c2-tl dorsal hardware fusion.There is multilevel degenerative disc disease and ventral osteophytosis, most profound from c4 through c6.There is no fracture, compression deformity, subluxation or bony destruction.Soft tissues are otherwise unremarkable.Impression; stable cervical spine radiographs comparison: on (b)(6) 2020 - 2 views of the cervical spine findings: frontal and lateral views of the cervical spine.Posterior fusion from c2 to tl again noted.Vertebral body height is fairly well maintained.Marked anterior bridging osteophyte again seen from c4 to c6 and moderate findings at c7/tl.There is no apparent fracture.Impression: no change procedure date: on (b)(6)2020 clinical history: spine cervical 2v, spine thoracic 2v; rom loss post fusion findings: ap and lateral thoracic spine views are obtained.No acute fracture or subluxation.Thoracic vertebral bodies demonstrate normal height and alignment.Intact partially visualized postop changes and fusion hardware are observed at tl and the cervicothoracic junction.There is multilevel degenerative disc disease and ventral flowing osteophytosis· consistent with diffuse idiopathic skeletal hyperostosis.There is no vertebral body compression or bony destruction.Remaining pedicles are intact and symmetric.Impression: no acute thoracic spine findings.Chronic multilevel degenerative changes, as described.Reference: on (b)(6) 2020 - cervical spine.Findings: ap and lateral views of the cervical spine were obtained.Stable postop changes and dorsal fusion hardware are again noted from c2 through tl.Hardware remains intact.Multilevel degenerative disc disease and ventral flowing osteophytosis is unchanged.There is no bony destruction or malalignment.Impression : stable cervical spine radio graphs.
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