MEDTRONIC SOFAMOR DANEK USA, INC. CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Device Problem
Break (1069)
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Patient Problems
Failure of Implant (1924); Neuropathy (1983); Pain (1994); No Known Impact Or Consequence To Patient (2692)
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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 per patient call that on (b)(6) 2018, the patient underwent a lumbar fusion procedure.On an unknown date, the head of implanted pedicle screw fractured.Hence, on (b)(6) 2019, the patient underwent a revision surgery.No other information is available now.
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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 presented for follow up visit for lumbar fusion l4-s1.She reported low back pain and was taking norco 5 mg when needed.She did not go to physical therapy.She denied nicotine intake.Patient underwent lumbar spine ap/lat/spot.The impressions were: status post l4-s1 decompression and instrumented posterior spinal fusion with instrumentation intact and appears to be developing a solid posterolateral arthrodesis without problems noted.
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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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Manufacturer Narrative
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Additional information: a1, a2, a4, b5, 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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Event Description
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It was reported that on: (b)(6) 2018: the patient underwent a fusion surgery at l4-s1.(b)(6) 2018: the patient underwent mri lumbar spine with and without contrast.The findings were: 1.Little bit of seroma fluid post operatively, but that is very atypical.2.No evidence of any other hardware complications.(b)(6) 2018: the patient presented with the following pre-op diagnoses: 1) postlaminectomy syndrome status post laminectomy, decompression and instrumented fusion l4¿s1 on (b)(6) 2018.2) neuropathic pain postoperatively status post instrumentation and fusion.(b)(6) 2018: the patient underwent emg test.The findings were: evidence of lumbar radiculopathy concerning for l5 and s1 involvement bilaterally.Additionally, she has superimposed diabetic peripheral neuropathy.This affects both motor and sensory nerves.12 dec 2018: the patient underwent lumbar spine ct without contrast.Impression: 1.Interval fracture of the left l5 pedicle screw.2.Mild levoconvex curvature of the lumbar spine.3.Small left lower pole renal calculus, unchanged.(b)(6) 2019: the patient underwent 4 x-ray views of lumbar spine.The impressions were: interval lower lumbar surgery, mild loss of the l3-4 also height, no definite abnormal motion identified with flexion or extension maneuver attempts.Radiologic interpretation: imaging review demonstrates left s1 pedicle screw fracture with some haloing.(b)(6) 2019: the patient came for follow up visit.The radiologic interpretation: motion across the l5, s1 level where a broken screw is present.Flex/extension shows change in angulation of screw.(b)(6) 2019: the patient underwent ekg test.The impressions were: pseudoarthrosis, interval fracture of the left l5 pedicle screw, chronic pain syndrome, insulin- dependent type 2 diabetes mellitus, recent hemoglobin, history of graves¿ disease status post radiation, stable on synthroid, dyslipidemia, hypertension, insomnia, history of tobacco use.04 feb 2019: the patient was presented with the following pre-op diagnoses: pseudoarthrosis l5-s1 and underwent following procedures: 1.Removal of l4, l5, s1 pedicle screws.2.Placement of l4, l5, s1 pedicle screws.3.Posterior lateral intertransverse fusion.4.Revision of pseudoarthrosis.As per operative notes, ¿midline incision was made through the lower portion of her prior incision exposing the hardware at lumbar 4-5 and sacral 1.With the assistance of the surgeon, who was present from opening to closure, i was able to carefully remove the hardware on the right-hand side, which included the rod and screw construct.A very obvious pseudoarthrosis has occurred.This was replaced with 6.5x45mm ha screws at l4 and l5 and a 7.5x45 hydroxyapatite screw at s1.I was happy with the right sided pedicle screw fixation.The left sided construct was removed.Of note, all pedicle screws on the left were very, very loose and were able to be unthreated with finger looseness.The s1 screw was fractured just below the head.Ultimately, there was enough of the pedicle screw visible that we were able to grab this with remover and removed the fractured distal tip of the pedicle screw.After i was happy with the removal of all hardware, 7.5x45 mm ha screws were placed at all level on the left hand side.These were placed in the prior pedicle screw channels.After i was happy with the placement of my pedicle screw construct, they were conn ected utilizing a 5.5x70 mm prebent rod.We extended this inferiorly and a small amount of compression was placed upon the s1 screw was connected via a cross connector to add stability.Facets and transverse processes were roughed up to bleeding bone.Given the fact that there was a pseudoarthrosis, rhbmp2/acs was utilized as well as graft.This was placed into the posterolateral intertransverse space, again after was roughed up to bleeding bone running from l4-s1.I was happy with the posterolateral fusion.Attention was turned to irrigation.Significant antibiotic irrigation was utilized with 1-0 stratafix, 0 vicryls, 2-0 vicryls and a 4-0 running monocryl.Dermabond completed the skin closure.¿ the patient underwent xr l- spine 2-3 views.The findings were: total of 10.1 seconds of fluoroscopic time was used.Transpedicular screws have been placed.New posterior interconnecting rods and additional hardware have been placed.The disc space remains in place.(b)(6) 2019: the patient got discharged from the facility.(b)(6) 2019: the patient came for follow up: post op lumbar two week post op hardware removal l4-s1 w/ pelvic fixation (b)(6) 2019.The patient underwent following procedure: lumbar spine- two views.The impressions was uncomplicated postoperative change following posterior lumbar interbody fusion of l4 to s1.Post-op x-ray: a/p lateral views reveal good positioning of implants, no evidence of loosening with solid fusion hardware intact at level l4-s1.
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Event Description
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It was reported that on: (b)(6) 2018: patient got discharged from the facility.Discharge diagnosis: 1.Intractable nausea and vomiting.2.Intractable pain.3.Nephrolithiasis, non-obstructing.4.Constipation.5.Diabetes.16 (b)(6) 2018: the patient was admitted to hospital.The patient was pre-diagnosed with: (i) right and left l4-5 herniated nucleus pulposus with spinal stenosis l4-5.(ii) low back pain.(iii) right greater than left lower extremity radiculopathy.Patient underwent following procedures: (i) decompressive lumbar laminectomy, l4-l5, l5-s1 for decompression bilateral l4,l5 and s1 nerve roots lateral to the pedicle.(ii) transforaminal lumbar interbody fusion l4-5, l5-s1.(iii) application of biochemical intervertebral device ,l4-l5, l5-s1 with plasma spray coated device with iliac crest autograft in the center.(iv) segmental pedicle screw instrumentation l4-l5, l5-s1 with titanium alloy pedicle screws, cobalt chrome rods.(v) right posterior iliac crest bone graft harvest through separate fascial incision, morselized.(vi) use of local laminectomy bone for augmentation posterolateral arthrodesis.As per op-notes, ¿patient received 1g of vancomycin prior to the start of the operative procedure.Patient had a scalpel used to make a midline skin incision in lumbosacral spine followed by use of electrocautery to dissect down through the subcutaneous tissues down to the posterior spine fascia.The posterior spine fascia was incised and the soft tissues were elevated off the spinous processes, lamina and transverse processes of l4, l5 and the sacral ala bilaterally.A radiopaque marker was placed, and intraoperative c-arm fluoroscopy was used to confirm our operative levels.After confirmation of operative levels, the patient had the approach to the right posterior iliac crest where the patient had soft tissues elevated off the posterior spine fascia over to the right posterior iliac crest.The fascia over the iliac crest was incised, elevated off just medially and laterally.The patient then had a taylor retractor placed and then soft tissues were removed from the posterior aspect of the iliac crest followed by rongeur used to open the posterior aspect of the iliac crest.Morselized bone was removed with a curette with care taken not to penetrate the sacroiliac joint or the inner or outer tables of the ilium.After sufficient bone graft was harvested the patient had the wound thoroughly irrigated with normal saline, bacitracin and pulsatile lavage.The patient then had floseal hemostatis solution in order to effect hemostasis.After hemostasis was achieved the patient then had the fascia over the iliac crest closed with#1 vicryl simple continuous type fashion followed by #1 vicryl simple continuous type fashion at dead space in order to obliterate this layer.The patient then had the posterior spine wound thoroughly irrigated with normal saline, bacitracin and pulsatile lavage.Followed by then, the decompressive lumbar laminectomy with complete facetectomies, foraminotomies carried out at l4-l5 to l5-s1 for decompression bilateral l4, l5 and s1 nerve roots lateral to the pedicle.Patient then had the large disk herniation on the right identified at l4-l5.The dura was retracted.The patient had a scalpel used to perform an annulotomy followed by pituitary rongeurs, curettes and disk endplate scrapers.Thorough discectomy was carried out.Decompression of the l4 and l5 nerve roots.The patient then had lamina spreader placed and appropriate sized plasma sprayed intervertebral device with the iliac crest autograft placed in the center was impacted in place.The patient had good smooth bleeding endplates for transforaminal lumbar interbody arthrodesis.Following this, the patient then had placement of thrombin-soaked gelfoam over the transforaminal lumbar interbody arthrodesis done in the same fashion at l5-s1.Patient then had the posterior spine wound thoroughly irrigated with normal saline, bacitracin and pulsatile lavage.The dura was protected and high speed burr was used to decorticate the transverse processes at l4,l5 and the sacral ala followed by a sharp awl used to penetrate the outer cortex pedicle then placement of pedicle finder then a straight holt probe in order to probe all 4 sides of the pedicle and then a 6.5x45 mm length titanium alloy pedicle screw was placed at l4, l5 and s1.Same thing was done on the opposite side.The patient then had stimulus-evoked emg carried out with all screws simulating greater than 15ma and the nerve root simulating approximately 3.5 to 5.5 ma.This indicated screws were not in contact with the nerve root.Ap and lateral c-arm fluoroscopy was taken which confirmed excellent placement of pedicle screws and the tlif rings.The posterior spine wound thoroughly irrigated with normal saline, bacitracin and pulsatile lavage.Then the iliac crest autograft was placed into the posterolateral gutters with local laminectomy bone which was cleaned of soft tissue morselized in a bone mill placed on top of that in order to augment the posterolateral arthrodesis.The patient then had a contoured cobalt chrome rod placed on pedicle screws followed by then an endcap.The construct was compressed posteriorly in order to increase the patient¿s lumbar lordosis and prevent extrusion of the tlif ring.The patient then had the outer portion of the endcap sheared off with a torque wrench thus locking the rod on the pedicle screws.Same thing was done the opposite side.The patient then had removal of the thrombin-soaked gelfoam from the tlif sites.The patient then had placement of aminox over the dura and exiting nerve roots in order to prevent scarring of the dura and exiting nerve roots in order to prevent scarring of the dura and exciting nerve roots followed by placement of tisseel fibrin glue and then closure of the posterior spine fascia with #1 vicryl in figure-of-eight suture pattern followed by #1 vicryl simple continuous type fashion posterior spine fascia in order to effect a watertight closure in this layer followed by normal saline bacitracin and pulsatile lavage posterior spine fascia followed by 2-0 vicryl simple interrupted buried type fashion subcutaneous tissue followed by 2-0 vicryl simple continuous subcutaneous fascia in order to effect a watertight closure in the subcutaneous layer followed by 3-0 vicryl simple continuous subcuticular pattern to close the skin followed by prineo/dermabond and a sterile nonadherent dressing over the drain.Sharp, sponge and instrument counts were correct.General anesthesia was terminated.¿ the patient underwent x-ray lumbar spine 2-3 views.Impressions: surgical instrument is positioned at the level of l5.Subsequent 2 segment lumbar sacral fusion with discectomy changes and l5 laminectomy changes.Straightened lordosis.On (b)(6) 2018: the patient was discharged from the hospital.The patient was post diagnosed with post decompression lumbar with instrumented posterior spinal fusion l4-5 and l5-s1 with probable urinary tract infection.On (b)(6) 2018: patient came for follow up visit.On (b)(6) 2018: the patient underwent mri lumbar spine with and without contrast.Impression: i) post-op posterior spinal fixation l4-s1.Bilateral laminectomy defects are demonstrated at the l4-5 and l5-s1 levels.No evidence of recurrent spinal canal stenosis or neural foraminal stenosis.Enhancing granulation tissue and/or scar is demonstrated about the traversing right l5 nerve root at the level of the l4-5 intervertebral disk.On (b)(6) 2018: patient came for follow up visit.On (b)(6) 2018: patient underwent ct scan of lumbar spine without contrast.
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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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