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| Model Number MSB_UNK_SCREW |
| Device Problem
Migration (4003)
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| Patient Problems
Pain (1994); Tingling (2171); Stenosis (2263); Injury (2348); Numbness (2415)
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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 as per a litigation complaint that the patient underwent a surgery.On an unknown date, post-op, due to increasing pain at the implanted site, the patient underwent an mri on (b)(6) 2019.The results showed multiple displaced screws in the patient.The results also showed fractured screws bilaterally at the s1 vertebra.On (b)(6) 2019, the surgeon performed a revision surgery.The patient's post-operative diagnosis was a failure of arthrodesis of lumbar instrumentation.Reportedly, the patient also suffered from unspecified injuries.
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Manufacturer Narrative
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For the initial regulatory report # 1030489-2020-00486, was populated incorrectly.The correct date is (b)(6) 2020.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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It was reported as per patient's medical records that on: (b)(6) 2018: patient was admitted to the hospital.Patient was pre-operatively diagnosed with 1) mechanical axial back pain.2) right lower extremity radiculopathy.3) spondylolisthesis of l5 on s1.4) herniated nucleus pulposus.The following procedures were performed, 1) l4 and l5 bilateral laminectomies.2) right-sided l4-l5, l5-s1 gill facetectomies.3) left-sided l5-s1 gill facetectomies.4) right-sided l4-l5 transforaminal lumbar interbody fusion using polyetheretherketone graft.5) posterior spinal instrumentation with pedicle screw and rod fixation at l4, l5 and s1.6) arthrodesis, l4 to s1.7) use of intraoperative radiograph.8) use of autograft.9) use of allograft.As per op notes, ¿¿we proceeded to identify the l4-l5 disc space on the right using intraoperative landmarks and x-ray.Next, an annulotomy with a #11 scalpel was performed and then the disc space was prepared in the standard fashion using sequential disc space scrapers.Once the disc space was appropriately displayed and significant discectomy was performed, we placed #11 trial within the disc space and performed intraoperative x-rays.Based on our intraoperative x-ray we opted to use a #12 peek cage.Prior to this the endplates were then prepared with curettes and the cartilaginous endplate was removed.The wound was then copiously irrigated, and the disc space was then packed with the patient's own autograft which was devoid of soft tissue and morselized.Next, a 12 mm x 26 mm cage was filled with the patient's own autograft and the meticulously under x-ray guidance placed within the l4-l5 disc space.Once we were satisfied with our transforaminal lumbar interbody placement of our graft for our arthrodesis, we turned our attention to the placement of our pedicle screws.The pedicles of l4, l5 and s1 were cannulated in standard fashion using the standard anatomic and radiographic markers.Using a high speed burr, a pilot hole was placed at each pedicle using anatomic and radiograph landmarks.Then each pedicle was then cannulated with gearshift and then a pedicle probe was utilized to ensure that there was no violation of the wall.Once we were satisfied with the integrity of each pedicle, the pedicles were tapped to a predetermined length and pedicle markers were placed and intraoperative radiographs were obtained.Once we were satisfied with our radiographs we proceeded with placement of our pedicle screws.At l4 we placed six 5 x 50 millimeter pedicle screws bilaterally.At l5 we placed 6.5 x 45 millimeter screws bilaterally and at s1 we placed 6.5 millimeter x 40 millimeter screws bilaterally.Next, the pedicle screws' tulip heads were then connected with a 55 millimeter rod and then set screws were utilized to attach the rods to the tulip heads and final tightened to the manufacturer's recommended torque limits.At this point the transverse processes of l4 and l5 as well as the sacral ala of s1 bilaterally were decorticated in preparation for our arthrodesis.Once the decortication was performed, the wound was then copiously irrigated and hemostasis was obtained with surgifoam.Excess surgifoam was then washed away with irrigation.Next, the patient's own autograft, which was morselized and devoid of soft tissue was placed in the lateral gutters for a posterolateral fusion and then we proceeded to place the allograft in the lateral gutters to aid with our arthrodesis.Once we were satisfied with this portion of the case, once again confirming x-rays were obtained in the ap and lateral plane which revealed appropriate anatomic alignment and hardware placement.Next, we turned our attention to the closure of the wound.The deep muscle fascia and sk in edges were then doused with vancomycin powder.¿ 15 may 2018: patient underwent x-ray of lumbar spine.Impression: status post interbody fusion at l4-l5 and posterior fusion and decompression at l4-s1, without acute complication identified (b)(6) 2018: patient was discharged from the hospital.(b)(6) 2018: patient came for follow up visit post l4/5 tlif with decompression and fusion of l4-s1.Patient underwent x-ray of lumbar spine.Impression: patient has recovered well from his surgery and his surgical incision is clean, dry, and intact.His surgical staples were removed and tolerated the procedure well.(b)(6) 2019: the patient came for follow up visit and underwent x-ray of lumbar spine.Findings: no acute change.Dextroscoliosis.Postop anterior interbody fusion, l4-l5.Postop posterior spinal fusion, l4-s1 bilaterally.The images are somewhat degraded secondary to patient body habitus.I cannot exclude fractures of the s1 screws bilaterally.(b)(6) 2019: the patient underwent ct lumbar spine wo contrast.Impression: 1.The patient is status post l4-s1 posterior fusion with mild to moderate loosening of the s1 screws.2.Again demonstrated is fracture of the bilateral s1 screws.3.No evidence of bony fusion of the interbody graft at l4-l5 or of the l4-s1 posterior elements.4.There is grade one anterolisthesis of l5 on s1 secondary to bilateral pars defects.There is moderate to severe bilateral neural foraminal narrowing.5.At l3-l4 degenerative spondylosis resulting in moderate bilateral neural foraminal narrowing and spinal stenosis.The patient underwent mri lumbar spine wo contrast.Impression: 1.Post-surgical changes of prior lumbar spine fusion are re-demonstrated with pedicle screws connected by vertical rods from l4 through s1.Susceptibility artifact related to the metallic surgical hardware degrades images and limits evaluation of the surrounding structures.2.Multilevel degenerative changes of the lumbar spine, which appear centrally most pronounced at l3-l4, where there is moderate spinal canal and subarticular zone stenosis as well as moderate (left greater than right) neural foraminal stenosis.3.Neural foraminal stenosis appears most pronounced at l5-s1, where it is judged to be at least moderate to severe (right greater than left).The patient underwent x-ray of lumbar spine.Impression: 1.Displaced fractures of the s1 screws near their he ads.2.Stable dextroscoliosis, spondylosis, and degenerative disc disease.(b)(6) 2019: patient came for follow up visit post-op l4-5 tlif and l4-s1 posterior spinal fusion.Impressions: patient had worsening of his back pain and new numbness and tingling associated with his left leg and anterior thigh.Lumbar spine x-rays revealed fractured s1screws in the pedicle.Ct scan of his lumbar spine also reveals fractured screws bilaterally at s1.There is also no significant evidence of arthrodesis.His latest mri does reveal adjacent segment stenosis at l3-4.Overall his alignment is stable and well maintained.(b)(6) 2019: the patient was admitted to hospital.The patient was pre-diagnosed with 1.Failure of arthrodesis and lumbar instrumentation.2.Adjacent segment disease at l3-l4.3.Mechanical axial back pain.The patient underwent following procedures: 1.Revision lumbar decompression, l3 to s1.2.Left-sided l3-4 transforaminal lumbar interbody fusion using 12 mm x 24 mm cage.3.Removal of i nstrumentation, l4 to s1.4.Re-instrumentation l3 to iliac.5.Arthrodesis, l3 to iliac.6.Sseps.7.Running emgs.8.Use of intraoperative neuronavigational.9.Intraoperative ct.10.Use of intraoperative fluoroscopy.As per op notes, ¿¿next, using the cutting cobb technique, we proceeded to elevate the significant scar tissue built up over the old hardware and then meticulously work our way laterally, exposing the transverse processes of l3, l4, l5, and the sacral ala of s1.Once our lateral exposure was obtained, in preparation for our decortication and arthrodesis we proceeded to remove the old hardware.Once the old hardware was removed, we used a self-backing system to remove the left s1 screw that was broken in the pedicle.We were unable to remove the pedicle screw at s1 on the right side.Once this was accomplished using intraoperative neuronavigation as well as fluoroscopy, we turned our attention to the placement of our instrumentation.Using anatomic and radiographic landmarks, i proceeded to place pilot holes at l3 bilaterally and then in standard fashion using a gearshift, a pedicle problem, and neuronavigation, proceeded to place holes at the l3 pedicles bilaterally.The holes then were tapped using an under-tapping technique, and we proceeded to place 6.5 x 60 mm screws bilaterally at l3.Next, the screws at l4-l5 were in appropriate trajectory and were just upsized.At l4, we placed 7.5 x 60 mm screws bilaterally.At l5, on the left we put 7.5 mm x 50 mm screw and on the right, we placed 7.5 mm x 45 mm screw.At the left s1, we upsized the screw to a 7.5 mm x 50 mm screw, and on the right a new trajectory was planned and then in standard fashion a 7.5 mm x 40 mm screw was placed as described previously for l3.Once the screws at s1 were done, then using anatomic and radiographic landmarks, we turned our attention to the placement of the s2 alar iliac screws.On the right, we proceeded to place a 9.5 mm x 90 mm screw; and on the left, we proceeded to place a 9.5 mm x 100 mm screw.We performed the sequential tapping technique to upsize our pilot hole and tap across the s1 joint in order to get the most appropriate purchase.Once the instrumentation was placed, next our attention was turned to the decompression.We proceeded to resect the spinous process of lamina of s1 with a leksell rongeur and then the remaining lamina was pinned with an ama matchstick and then the ligamentum flavum and remaining lamina was resected with kerrison 3, 4, and 5 rongeurs.Once we had significant decompression of the severely stenotic l3-4 segment, we performed a leftsided gill facetectomy at l3-4 using a high-speed bur and kerrison rongeurs.Once the gill facetectomy was performing, an exiting l3 nerve root was identified and then the disc space was prepared for our left-sided transforaminal lumbar interbody fusion at l3-4.Once the disc space was prepared, a #11 blade was utilized to perform an annulotomy and then disc space shavers were utilized to remove the disc material as well as the utilization of pituitary rongeurs.The endplates were then prepared and devoid of the cartilaginous endplate and a trial was placed in and fluoroscopy was obtained to ensure that we had appropriate sizing.Once we were satisfied with this, the wound was copiously irrigated and then anterior disk space was then packed with the patient's own bone which was morcellized and devoid of soft tissue.Next, a cage, which measured 12 mm x 24 mm, was packed with the patient's own autograft and then meticulously positioned within the disc space under direct visualization and fluoroscopy.Once our tlif graft was placed for our arthrodesis at l3-4, we proceeded with the remainder of the decompression.There was significant overgrowth of scar tissue from l3 down to s1 which we proc eeded to meticulously dissect and perform revision decompression and foraminotomies at l4-5 and l5-s1 bilaterally.Given the significant amount of scar tissue, this portion of the operation added an extra 3 hours to the case that was due to his excessive scar growth.Once our revision decompression was satisfactorily performed, a woodson was utilized to interrogate the neural foramina that revealed no further decompression.It should be noted that patient had developed a synovial cyst at l4-5 on the left that required removal which was causing severe stenosis at this previously decompressed level.However, we were able to meticulously dissect the synovial cyst off the thecal sac and remove it and decompress the nerve root on the left.Once we were satisfied with our decompression and placement of our pedicle screws, we turned our attention to the decortication portion of the case.The transverse processes of l3, l4, l5, and sacral ala of l1 and s2 were decorticated using high-speed bur.Once the decortication process was performed, the wound was then copiously irrigated, and we proceeded to fashion 220-mm rods to place within the tulip screws bilaterally.Given the patient's previous failure of arthrodesis and hardware failure, we opted to perform a dual technique, and once the rods were placed we proceeded to place a 100-mm rod and utilized 3 dominos on the left and 2 dominos on the right to attach the secondary rod to the primary rod that was attached to the tulip heads.Once the rods were fabricated and bent to meet anatomic alignment, they were placed in the tulip heads and secured to the tulip heads with set screws.Next, the set screws were then final tightened to the manufacturer's torque limits and then the secondary rod was also then final tightened to the manufacturer's torque limits.Once this was obtained, ap and lateral x-rays were performed to ensure that we had appropriate alignment and instrumentation.Once we were satisfied with this, we proceeded to place in the lateral gutters a medial kit of bmp over the transverse processes.The patient's own bone was then also placed in the lateral gutters for arthrodesis and then one 20 cm graft strip was then placed in the lateral gutters to aid with arthrodesis.Prior to the placement of our graft strips, we had harvested iliac crest aspirates and ensured that the graft was soaked in this iliac crest aspirate.Upon the placement of our bone graft for arthrodesis, the wound was then inspected and bipolar electrocautery was utilized to obtain immaculate hemostasis¿.Then our attention was turned to the closure of the wound¿¿.(b)(6) 2019: the patient was discharged from hospital.
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Manufacturer Narrative
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Additional information: a1, a2, a5a, a5b, b5, b6, b7, d7, h6 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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Medical advisor interpretation: post op ap for the lumbar cervical fusion.On provided images the s1 screw are fractured.By report, other hardware complications are present.Original post op xrays show an l4-5-s1 construct.It appears this was revised to l3.Line construct and the fractured screws were left in place.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 received on 16-aug-2021: medications: ketorolac (toradol) injection, mannitol, adenosine, atropine, calcium chloride, calcium gluconate, naloxone, sodium bic arbonate, vasopressin, phenylephrine bolus, amiodarone bolus, esmolol, milrinone, procainamide, ecmo patient heparin bolus, lorazepam, fosphenytoin, phenobarbital, leviracetam, diazepam rectal, midazolam intranasal, neosporin, cefepime, betadine, amoxicillin- clav ulanate, dexmedetomidine, dapagliflozin, famotidine, alum & mag hydroxide-simeth, gadoterate meglumine, magnesium hydroxide, melatonin, oxycodone immediate release, oxycodone-acetaminophen, bupivacaine pf, bisacodyl, calcium carbonate, methocarbamol, methylp rednisolone.(b)(6) 2018: the patient came for a follow-up visit with back and leg pain.(b)(6) 2018: patient was taken to the hospital in an ambulance for shortness of breath.(b)(6) 2019: the patient came for a medication follow-up.(b)(6) 2019: the patient had a si joint injection.(b)(6) 2019: the patient came for a follow-up visit.(b)(6) 2019: the patient came for a follow-up visit and had a sacroiliac joint injection.(b)(6) 2020: the patient underwent xr l spine ap and lateral-standing.Impression: stable posterior fusion of l3 to the pelvis.(b)(6) 2020: the patient came for hip pain and decreased urine flow.Patient underwent ct lumbar spine wo contrast.Impression: 1.Status post l3 through bilateral iliac posterior fusion without hardware fracture or loosening.2.There is solid bony fusion of the l3-s1 posterior elements.3.At l2-l3 degenerative spondylosis resulting in moderate left greater than right neuroforaminal narrowing and spinal stenosis.Patient is discharged.(b)(6) 2020: the patient admitted to emergency department complaining of left foot infection caused due to accidentally stubbing his left second toe.Patient was found to have evidence of cellulitis of the left second toe.Mri of the foot confirmed osteomyelitis of the distal and second phalanges of the second toe.Patient had xr foot comp min 3 vws lt.E findings: no bone or joint abnormality is seen.No fracture is detected.No foreign body is identified.Tarsal - metatarsal alignment is anatomic.No articular erosion is present.Well corticated enthesophyte formation is present at the calcaneal insertion of the achilles tendon and the plantar aponeurosis.(b)(6) 2020: the patient had mri foot lt wo & w con.Impression: 1.Distal second toe soft tissue ulceration and sinus tract formation with underlying erosive change and osteomyelitis involving the second toe distal phalanx.2.No drainable soft tissue fluid collection identified.3.Denervation atrophy changes of the intrinsic musculature of the foot.(b)(6) 2020: the patient underwent partial left second toe amputation.Patient had xr foot comp min 3 vws lt.Impression: 1.Status post amputation at the level of the mid proximal phalanx of the second digit with surrounding postoperative change.(b)(6) 2020: the patient was discharged.(b)(6) 2020: the patient came for a follow-up visit.(b)(6) 2020: the patient came for a follow-up visit.(b)(6)2020: the patient came for a follow-up visit.(b)(6) 2021: the patient visited hospital for cold and hip pain.Patient had xr l spine comp w obliques.Impression: 1.Bilateral posterior fusion l3-s1 and interbody fusion at l3-l4 and l4-l5.2.Right pedicle screw at s1 appears fractured but this appears unchanged.3.Multilevel spondylosis with spurring of the endplates and mild dextroscoliosis.(b)(6) 2021: the patient came for a follow-up visit.
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Manufacturer Narrative
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Additional information added in b5.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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Medical advisor interpretation: ct spine.Saggital mri l4-5 fusion.X-ray ap/oblique l-4/5.Several screws appear fractured bilaterally.Fusion status unknown.There is a possibility of one in the interbody space and on the posterior elements on the provided ct of the lumbar spine.Additional information added in b5.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 received on 04-oct-2021: medications: pravastatin, proair hfa 90 mcg/actuation aerosol inhaler, advair.(b)(6) 2016: the patient came to hospital with back pain.(b)(6) 2016: the patient came for a follow-up visit.(b)(6) 2016: the patient came for a follow-up visit.(b)(6) 2016: the patient came for a follow-up visit.(b)(6) 2016: the patient came for a follow-up visit.(b)(6) 2016: the patient came for a follow-up visit.(b)(6) 2016: the patient came to hospital for dizziness.(b)(6) 2016: the patient came for a follow-up visit.(b)(6) 2016: the patient came to hospital for a health maintenance exam.(b)(6) 2017: the patient came for a follow-up visit for chest pain and had a chest x-ray.Impression: no acute cardiopulmonary disease.(b)(6) 2017: the patient came for a follow-up visit.(b)(6) 2017: the patient came for a follow-up visit.(b)(6) 2017: the patient came for a follow-up visit.(b)(6) 2017: the patient came for a follow-up visit.(b)(6) 2017: the patient came for a follow-up visit.(b)(6) 2017: the patient came for a follow-up visit.(b)(6) 2018: patient had a mri of the right thigh with and without contrast.Impression: 1.There is no mass lesion, fluid collection, or inflammatory process identified at the lateral aspect of the distal right thigh and right knee to account for the patient's palpable mass.2.Mild patellofemoral and medial compartment osteoarthritis of the right knee.(b)(6) 2018: the patient came for a follow up visit.(b)(6) 2018: the patient came for a follow up visit (b)(6) 2018: patient had physical therapy from (b)(6) 2018 to (b)(6) 2018.(b)(6) 2018: patient came for a follow-up visit.(b)(6) 2018: patient came for a follow-up visit.(b)(6) 2018: patient came for a follow-up visit.(b)(6) 2019: patient came for a follow-up visit.(b)(6) 2019: patient came for a follow-up visit.(b)(6) 2019: the patient came for follow up visit.(b)(6) 2019: the patient underwent mri of the lumbar spine with and without iv gadolinium 14cc gadavist contrast.Impression: extensive postoperative changes with posterior spinal decompression and posterior spinal instrumentation from l3 to s1.Intact instrumentation by mr.L3-4 and l4-5 discectomies.Marrow edema and suspected marrow enhancement within the l3 and l4 vertebral bodies.This is nonspecific in the perioperative time frame.Underlying infections considered unlikely given the absence of disc pathology and based on clinical history.(b)(6) 2019: the patient came for a follow-up visit.(b)(6) 2019: the patient came for a follow-up visit.And had x-ray hip with or without pelvis 2-3 view right.Impression: post-operative changes in the lumbosacral spine.Hip joints are normal bilaterally.No acute abnormality.(b)(6) 2019: the patient came for a follow-up visit.(b)(6) 2020: the patient came for a follow-up visit.(b)(6) 2020: the patient came for a follow-up visit.(b)(6) 2020: the patient came for a follow-up visit.(b)(6) 2021: the patient came for a follow-up visit.(b)(6) 2021: the patient visited hospital for hip pain.Updated information received on (b)(6) 2021: (b)(6) 2017: patient visited the hospital for fl guided pain management and received a lumbar epidural injection.(b)(6) 2018: patient came for follow up visit.(b)(6) 2018: patient came for follow up visit.(b)(6) 2018: patient came for follow up visit.(b)(6) 2018: patient came for follow up visit.(b)(6) 2018: patient came for follow up visit.(b)(6) 2018: patient came for follow up visit.(b)(6) 2019: patient came for follow up visit.(b)(6) 2019: the patient came for follow up visit.(b)(6) 2019: patient came post-operative follow up and surgical staple removal.(b)(6) 2019: the patient came for follow up visit.(b)(6) 2020: the patient came for a follow-up visit.(b)(6) 2021: the patient came for a follow-up visit.(b)(6) 2021: the patient came for a follow-up visit and received fluoroscopic guided lumbar interlaminar epidural steroid injection at t12-l1 space (b)(6) 2021: the patient came for a follow-up visit with leg pain and had duplex us venous ext low lt.Conclusions: left lower extremity with no evidence of deep or superficial vein thrombus.
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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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Updated information received on 03-nov-2021: 12-jul-2019: the patient had home health care from (b)(6) 2019 to (b)(6) 2019.On (b)(6) 2019: the patient had home health care from 16-jul-2019 to 13-aug-2019.Updated information received on 11-nov-2021: patient had physical therapy on the following dates: (b)(6) 2018, (b)(6) 2019, and (b)(6) 2021.On (b)(6) 2020: on this date the patient discontinued therapy due to insurance visit limitations.On (b)(6) 2021: the patient is discharged due to non-compliance.
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Search Alerts/Recalls
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