MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 1555200500

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

Product identifier is unknown, hence 510k# is not available.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.

Event Description

Information was received from the consumer via a medtronic representative regarding a patient implanted with a rod for an unknown spinal indication (post-op).It was reported that the patient's spine rod broke at the l5-s1 level within 2 years of implantation.The revision surgery was on (b)(6) 2019.The surgeon allegedly thought there was a defect in the rod.No further complications were reported/ anticipated.

Event Description

Information was received from the consumer via a medtronic representative regarding a patient implanted with a rod for a spinal fusion posterior thoracic/ lumbar 3+ levels- hardware revision.It was reported that the patient's spine rod broke at the l5-s1 level within 2 years of implantation.The revision surgery was on (b)(6) 2019.The surgeon allegedly thought there was a defect in the rod.On (b)(6) 2017: he stated that he had also been told that he suffered from scoliosis and is concerned about this.He said that he had been approached with the idea of a spinal cord stimulator, but he did not feel that it would be helpful.As a result, he wished to discuss surgical options.He denied any bowel or bladder complaints and denies any overt leg weakness.He denied any falls as well.He stated that he had undergone epidural injections, as well as a radiofrequency ablation.He had completed a physical therapy regimen and is on oral narcotic medication.Past medical history was significant for hypertension and copd.Prior to any type of operative intervention, smoking cessation is a must.They will see the patient back when the above studies are completed.On (b)(6), 2017: the patient was ordered an external mri for lumbar spine by dr.(b)(6), non-(b)(6) x-ray imaging for patient with lower back pain by dr.(b)(6), non-(b)(6) ct imaging for patient¿s scoliosis evaluation by dr.(b)(6).On (b)(6) 2020: follow -up - neurosurgery by (b)(6) rn to discuss surgery.On (b)(6) 2017: the presenting complaint is evaluation for back pain.The patient has a history of l4-5 laminectomy in the past about 15 years ago for left leg radiculopathy which had not improved.He had 3 main complaints: severe back pain which was there all the time and did not improve with lying or with activity.He liked to flex his back to help with the pain; he complained of left leg radiculopathy which had not improved since his laminectomy, where he felt that he could live with that pain; he had severe stabbing pain in between his shoulder blades, which was the least important for him at that point.He denied any numbness/tingling, any weakness or any bowel/bladder control problems.He had a history of cervical diskectomy and fusion and lumbar laminectomy.Physical examination showed that the patient was alert and awake.Cranial nerves were intact.Motor strength was 4/5 in lower extremities diffusely and 5/5 bilaterally upper extremities.The weakness in lower extremities was pain-limited.Otherwise sensation was intact to light touch.The patient was stooped forward to help with the back pain.He had multilevel degenerative changes of foraminal stenosis at multiple levels.Smoking cessation clinic note: information regarding smoking cessation was sent to the patient's home address.Information included: (b)(6) smoking cessation clinic pamphlet (including contact numbers) and quitline iowa brochure.The patient was encouraged to call their clinic to receive assistance with quitting.On (b)(6) 2017: patient visit.Patient¿s chief complaint was low back and bilat leg pain.Informed consent for surgery obtained.They reviewed the patient's most recent scoliosis films that show significant left-sided curvature.Assessment: evaluation for low back pain.They have recommended correction of the scoliosis and decompression at l3-4, 4-5, and doing a t10 to ilium fusion.The patient understood the risks and complications of the procedure and would like to proceed with the surgery.Fluoro c-arm was ordered by dr.(b)(6) for intra-op positioning.On (b)(6) 2017: pre-op evaluation documentation.On (b)(6) 2017: inpatient consult rhb - (b)(6) physical therapy ¿ evaluate and treat, chest - ap/pa for s/p spinal fusion, evaluate fluid status, and ett, abdomen ap supine to verify ng ordered by dr.(b)(6).Results of chest- ap/ pa for status post spinal fusion and evaluation of fluid were compared to chest radiographs from (b)(6) 2017.Findings showed that the endotracheal tube terminated just below the thoracic inlet about 10cm superior to the carina.The lungs were hyperaerated consistent with emphysematous changes.There was no large area of focal consolidation.The pulmonary vasculature did not appear congested.No pneumothorax or evident pleural effusion.Enteric tube terminated in the gaseously distended stomach.Postsurgical changes of lower thoracic to sacral spinal fusion with surgical drain and skin staples in place.Partially visualized cervical spinal fusion hardware.Impression was interval retraction of the endotracheal tube which now terminated just below the thoracic inlet and could be safely advanced about 5cm, interval increased gaseous distention of the stomach where the enteric tube courses inferior to the diaphragm, and no pulmonary vascular congestion.Results for chest- ap/ pa for s/p spinal fusion.Findings showed that mediastinal/hilar, cardiovascular, upper abdomen, and lungs/airways/pleura were normal; bones/chest wall: cervical spinal fusion hardware and thoracolumbar spinal fusion hardware was partially visualized; lines/tubes/devices: endotracheal tube terminated approximately 6cm above the carina.Enteric tube terminated in the distal esophagus, advancement was suggested.Impression was that endotracheal tube was in appropriate position and enteric tube terminated in the distal esophagus, advancement was suggested.Results for abdomen ap supine for status post ng tube placement, to check position.Technique used was supine portable radiograph of the lower chest and upper abdomen.Findings/ impression showed that the tip of the ng tube is located in the gastric body and is partially obscured by overlying hardware.L spine ap & lateral for t9- ilium ordered by dr.(b)(6) [results: technique used was ap and lateral views of the lumbar spine and was compared with films from (b)(6) 2017, findings showed postsurgical change following posterior lumbar and lower thoracic spinal fusion without evidence of interval complication.Interval improvement in lumbar levoscoliosis but otherwise stable alignment.There are 5 lumbar type vertebrae.Alignment is anatomic.No acute fracture or dislocation.Disc spaces and vertebral body, impression was interval improvement in lumbar levoscoliosis with otherwise stable alignment.] on (b)(6) 2017: preoperative diagnosis: kyphoscoliosis of the lumbar spine with severe back and bilateral leg pain.Procedure p performed: t9 to ileum posterior fusion; transforaminal interbody fusion at l4-l5, l5-s1; bilateral first facetectomies at l2-l3, l3-l4, along with decompression.Indications: the patient was complaining of severe and worsening low back pain with bilateral leg pain.He was found to have severe kyphoscoliosis.Decompression and posterior fusion was indicated.Risk and benefits were discussed and appropriate consent was obtained.Procedure in detail: the patient was brought to the operating room.He was intubated with general anesthesia, was turned prone on an osi bed.Midline incision was marked, prepped and draped.A 10 blade was used to make a midline incision.Miskamin was used for self-retaining retraction.Blunt dissection was continued with monopolar cautery, following which the t9 level was identified with the help of fluoroscopy and following screws were placed: at t9: 5.5 into 40 bilaterally.At t10, 6.5 into 45 bilaterally.At t11: 6.5 into 50 bilaterally.At t12: 6.5 into 50 bilaterally.At l1: 6.5 into 50 bilaterally.At l2: 7.5 into 60 on the left side and 7.5 into 55 on the right side.At l3: 7.5 into 60 on the left side and 7.5 into 55 on the right side.At l4: 7.5 into 55 bilaterally.At l5: 7.5 into 50 bilaterally.At s1: 7.5 into 35 bilaterally.In ilium, on the left side: 8.5 into 90 screw was placed and 8.5 into 80 screw was placed on the right side.Once the screws were placed and the patient was confirmed with the lateral and ap fluoroscopy, following which our attention was directed towards the bony decompression and transforaminal interbody fusions were performed at l4-l5 and l5-s1 and bilateral facetectomies were performed at l2-l3, l3-l4.There was dural tear during the procedure.The dural tear was sutured with two 6.0 prolene sutures.There was a minimal leak with the valsalva maneuver.Duraseal was placed and once all the rods were placed bilaterally, bone was placed along the rods and hemovac drain was placed wound was closed in layered fashion.Vancomycin powder was placed prior to the closure.Staples were placed to approximate skin.The patient tolerated the procedure well.He was extubated and transferred to the (b)(6) without any acute complications.Procedure performed was spinal fusion posterior thoracic/ lumbar 3+ levels (bilateral back) by dr.(b)(6) (neurosurgery service).Medtronic products were used in the initial surgery.On (b)(6) 2017: inpatient consult anesthesia - pain service, inpatient consult rhb - (b)(6) physical therapy - evaluate and treat ordered by (b)(6) do.Patient underwent placement of lumbar drain.Pre-op diagnosis was csf leak.Description of operation ion/procedure: the puncture site was identified and the incision area was surgically draped in the usual fashion.A large bore 16 gauge tuohy needle was inserted into the l4-l5 space.The needle was advanced slowly and cerebral spinal fluid was obtained.The stylet was removed and an epidural catheter was inserted into the subarachnoid space.The needle was removed and the catheter was attached to a stopcock and secured with tevdek tie.The drain patency was evaluated and found to be patent.Csf was collected and sent for routine studies.The stopcock was connected to an epidural drainage system with confirmation of good csf flow.The connector was dressed sterilely with gauze dressing and a transparent adhesive dressing was used to secure the epidural catheter to the patient.The patient tolerated the procedure well.There was no blood loss or hematoma.Pain assessment post- procedure: pain in back at surgical site.On (b)(6) 2017: sicu interval assessment results were a patient who is s/p t9-ileum spinal fusion, was extubated on (b)(6) 2017.Acute pain consulted for pain regimen.Currently pod#2, on bedrest per nsg, tolerating diet.High wound vac output, worrisome due to dural tear intraop.Condition: critically ill.Clinical note assessment by (b)(6) was a patient with chronic back pain 2/2 scoliosis who had been on long acting opioids for several years.On (b)(6) 2017: inpatient consult rhb - (b)(6) physical therapy - evaluate and treat, inpatient consult rhb - occupational therapy - evaluate and treat, l spine ap &> lateral for t9-1ilium fusion, scoliosis standing pa & lat for t9- ilium fusion ordered by dr.(b)(6).On (b)(6) 2017: inpatient consult internal medicine - surgical co-management services by (b)(6) arnp.Ct brain wo contrast for headaches [results: technique used was axial ct of the brain without iv contrast.Sagittal and coronal reformations are also provided for review, findings showed that there was no evidence of acute large vascular distribution infarct, mass lesion or hemorrhage.Mild parenchymal volume loss otherwise the ventricles, cortical sulci and basal cisterns were symmetric and age appropriate.Normal brainstem and posterior fossa.The scalp and calvarium were unremarkable.Left sphenoid sinus disease.Partially visualized left maxillary sinus disease, impression was that there was no acute intracranial findings] ordered by dr.(b)(6).Inpatient assessment showed that patient continued to be limited by hypotension and high intensity pain, but the orthostasis had improved since last session.Patient demonstrated signs of potential meningeal irritation or csf leak, to which rn and arnp were alerted following session.Patient continued to require increased assist for transfers and was still unable to progress to ambulation today.Patient was unsafe to return home and would benefit from acute rehab at dc.Patient presented with decreased functional mobility and transitional movements with adl.He reported a high level of pain and difficulty with sustained attention due to this pain.He needed a high level of care at that time and would benefit from an inpatient rehab placement prior to return home to maximize his function al recovery and safety with adl/iadl.Patient was admitted due to left leg pain and scoliosis status post t9 to ilium fusion, l2-3, l4-5¿s1 tlif.Postop complicated by csf leak which was repaired.They were consulted for orthostatic hypotension.Hypotension likely secondary to poor p.O.Intake as well as overtreatment of high blood pressure as this patient only takes his bp medicine once a week.On (b)(6) 2017: inpatient assessment showed that patient continued to be limited by high intensity ha pain that increased with upright position and quickly resolved with return to supine, which was indicative of possible csf leak.Patient demonstrated no symptomatic drop in bp.Rn, arnp, and md were notified of continued symptoms indicating csf leak.Pt continued to progress patient mobility as able.On (b)(6) 2017: l spine ap & lateral for t9-1ilium fusion [results: indication was back pain, status post t9 to iliac fusion, technique used ap and lateral views of the lumbar spine and was compared to multiple prior x-rays, most recent dated (b)(6) 2017.Findings/ impression showed stable postsurgical changes of posterior spinal fusion of the lower thoracic and lumbar spine without evidence of interval hardware complication.Stable alignment of the lower thoracic and lumbar spine.No acute fracture or dislocation.The vertebral body heights were maintained.The remainder of the exam was stable and unremarkable.], scoliosis standing pa & lat for t9-ilium fusion ordered by dr.(b)(6).Inpatient assessment: patient continued to be limited by high intensity ha pain that quickly subsided with return to supine position, which continued to indicate potential csf leak.Patient was able to progress to ambulation today w/fww and one person assisted and stated that has are improving, but still present.Pt continued to progress patient mobility as able, but patient may need advanced medical intervention for management of has.On (b)(6) 2017: patient was discharged.Hospital course: patient was admitted on the day of surgery.His surgery was complicated by csf leak.A ld was placed and patient put on flat bedrest for 5 days.Ld was removed and patient ambulated.He initially had positional headaches but his wound remained dry.His headaches continued to improve and he was cleared by pt to be discharged to inpatient rehab.Results reviewed: x-ray: unremarkable for acute complications.Condition on discharge: on discharge, the patient was afebrile and his vitals were stable.Follow-up ¿ neurosurgery, scoliosis standing pa & lat for t9-ilium ordered by (b)(6) arnp.On (b)(6) 2017: final results of scoliosis standing pa & lat by (b)(6) arnp was received.Clinical indication was back pain and was compared to films from (b)(6) 2017.Findings / impression showed stable postsurgical changes of anterior spinal fusion of cervical spine and posterior spinal fusion of the lower thoracic and lumbar spine without evidence of interval hardware complication.Stable alignment of the lower thoracic and lumbar spine with mild levoconvex lumbar scoliosis.No acute fracture or dislocation.The vertebral body heights were maintained.The remainder of the exam was stable and unremarkable.On (b)(6) 2018: final results of scoliosis standing pa & lat by dr.(b)(6) was received.Clinical indication was bilateral leg pain and was compared to multiple prior studies, most recent x-ray dated (b)(6) 2017.Findings / impression: stable post surgical changes of t9 through bilateral iliac posterior spinal fusion.Stable postsurgical changes of acdf in the cervical spine.No evidence of interval hardware complication.Stable alignment of the spine with persistent mild levoscoliotic curvature.No evidence of acute fracture or dislocation.The remainder of the study was stable and unremarkable.Neurosurgery clinic results showed no hardware failure and no hardware complication or pjk based on the scoliosis x-rays.On (b)(6) 2019: ct chest with contrast results showed prominence of the aorta without evidence of an aortic dissection.Ascending aortic measuring 3.8 x 3.8 cm, bullous emphysematous changes in the lungs bilaterally, degenerative disease in the thoracic and lumbar spine and in the shoulders in this patient with harrington rods in the lower thoracic and lumbar spine.On (b)(6) 2019: final results of scoliosis standing pa & lat by dr.(b)(6).Indication was other idiopathic scoliosis, site unspecified, f/u hardware and was compared with dx spine (b)(6) 2018.Findings/ impression: post- surgical changes of t9 through bilateral iliac posterior spinal fusion.There was minimal lucency surrounding the t9 screws, unchanged.Stable postsurgical changes of acdf of the cervical spine.There was fracture of the left vertical rod between l5 and s1.No change in the alignment of the spine and appearance of the discs.Neurosurgery clinic assessment by dr.(b)(6) showed that patient presented with s/p t9-ileum fusion who had development of back pain recently.Imaging showed rod breakage with likely resultant stress causing bending in rostral aspect of construct.This was indicated for hardware revision with rod replacement.Risks, benefits, and alternatives to the procedure had been discussed with the patient and informed written consent has been obtained.The risks discussed include but are not limited to infection, bleeding, muscle weakness, numbness, paralysis, seizure, stroke, pneumonia, blood clots, mi, coma, death, failure of procedure, and re-operation, need for future revisions, failure to relieve back pain.Patient wished to proceed.The plan was for hardware revision in or with dr.(b)(6) on (b)(6) 2019.On (b)(6) 2019: patient underwent a ct thoracic and lumbar spine without contrast.There was an indication of breakdown (mechanical) of internal fixation device of vertebrae, initial encounter, pre op for hardware revision.The technique used was axial ct images of the thoracic and lumbar spine were obtained from c7 to s3 disc space without administration of intravenous contrast.Coronal and sagittal reformatted images were generated reviewed.It was compared to the ct spine from (b)(6) 2017.Findings included a partially visualized anterior spinal fusion hardware including c5 and c6, postoperative changes of t9 through bilateral iliac posterior spinal fusion.The right t9 screw extends through t8-t9 intervertebral disc with reactive endplate changes above it.There is mild anterior wedging of the t8 vertebral body.Inferior endplate degenerative changes of t6, t7, and t8.Spinal canal is normal.Bilateral emphysematous changes of the lung apices, right greater than left.Peri-vertebral soft tissues are normal (t-spine).There is convex lower thoracic and lumbar levoscoliosis.Postoperative changes of t9 through bilateral iliac posterior spinal fusion.Interbody spacers of l2-l3, l4-l5, and l5-s1.The left posterior spinal fusion rod is fractured at the l5-s1 level.Vertebral body heights are maintained.Multilevel degenerative changes.Spinal canal is unremarkable.Infrarenal abdominal aortic ectasia and vascular calcifications (l-spine).Impression was that postoperative changes of t9 through bilateral iliac posterior spinal fusion with fracture of the left vertical rod at the l5-s1 level and extension of the right t9 screw through the t9 superior endplate.On (b)(6) 2019: pre-op note by dr.(b)(6): patient who presents with prior t9-ilium fusion who has rod breakage and hardware revision is indicated.Risks, benefits, and alternatives to the procedure have been discussed with the patient and informed written consent has been obtained.The risks discussed include but are not limited to infection, bleeding, muscle weakness, numbness, paralysis, seizure, stroke, pneumonia, blood clots, mi, coma, death, failure of procedure, and re-operation, csf leak, hardware failure, adjacent disease, failure to relieve symptoms.Labs reviewed.Has possible uti.Will give ciprofloxacin.Chief complaint: back pain.History of present illness: patient has s/p t9-ilium fusion with l3-s1 interbody on (b)(6) 2017 who presents with back pain x2 months.He was doing okay and then felt pinch between shoulders/ above the "metal".Leaning forward caused back to lock up and spasm.He had baseline bilateral foot neuropathy and finger tingling since surgery.He had been taking baclofen which helps slightly.Pre-op diagnosis was hardware failure; bilateral rod fracture.Assessment: patient with a past medical history of t9-ileum fusion with failed hardware admitted on (b)(6) 2019 with s/p hardware revision with replacement of bilateral loose t9 pedicle screws and extension of fusion to t8 with replacement of bilateral fractured rods.Patient¿s performance was limited by significant orthostatic hypotension and pain.Indications: the patient presented with prior t9-ilium fusion who has rod breakage and hardware revision was indicated.Risks, benefits, and alternatives to the procedure had been discussed with the patient and informed written consent had been obtained.The risks discussed include but are not limited to infection, bleeding, muscle weakness, numbness, paralysis, seizure, stroke, pneumonia, blood clots, mi, coma, death, failure of procedure, and re-operation, csf leak, hardware failure, adjacent disease, failure to relieve symptoms.Patient was admitted in the hospital for spinal fusion posterior thoracic/ lumbar 3+ levels- hardware revision by dr.(b)(6) (neurosurgery service).Operation: 1.Removal of prior bilateral rods and bilateral t9 pedicle screws.2.Placement of bilateral t8 and t9 pedicle screws, use of cement in t9 fenestrated screws.3.Placement of bilateral new rods.4.Bilateral laminectomy and decompression at t9/t10.5.Use of intraoperative fluoroscopy.6.Use of autologous bone for fusion.7.Use of cortico cancellous bone for fusion.8.Use of osteoamp for fusion.Procedure details: the patient was brought into the main or and placed under general anesthesia.He was turned prone onto the operating table and prior incision site was marked.He was prepped/draped in usual sterile fashion.Timeout was performed and local anesthetic injected into the incision site.10 blade was used to cut skin and monopolar used to dissect down to spinous process.Dissection was carried out laterally to expose bilateral hardware and self retaining retractors were used throughout for exposure.Set screws of old hardware was removed.The old connector was removed.Bilateral old rods were removed.The screws were tested for purchase with kocher and bilateral t9 screws were noted to be loose.Decision was made to remove and replace these.6.5x45 fenestrated screws were placed in prior pedicle screw sites after old ones removed.Decision was then made to extend one more level to t8.Drill was used to decorticate bone, gear shift to create trajectory, feeler to ensure no cortical violation, tap to create screw trajectory, feeler to ensure no cortical violation, and screw subsequently placed.Screw placement was guided by fluoroscopy.5x5x45 hydroxyapatite screws were used for bilateral t8 pedicles.Cement was then placed into the fenestrated screws in t9 bilaterally.There was some extrusion of cement around right t9 pedicle screw entry zone and therefore bilateral laminectomy was performed at t9/t10.The thecal sac was seen to be adequately decompressed afterward with no evidence of intrusion of cement into the canal.Next malleable was used to estimate rod size and ultimately dual bend rods were fitted bilaterally and secured with set screws/reducer.Once adequate hardware placement was confirmed on fluoroscopy, set screws were final tightened.Wound was thoroughly irrigated with bacitracin wash and hemostasis ensured with bipolar.Gelfoam was used to cover thecal sac.Combination of autologous bone, corticocancellous bone, and osteoamp fiber was then placed along the hardware/adjacent bone surface for fusion.Hemovac was tunneled out of the wound bed.Vancomycin powder was applied.Muscle/fascia was closed with 0 vicryl.Fat was closed with 2-0 vicryl and dermis as well.Skin was closed with 3-0 nylon and drain secured with nylon.Wound was sterilely dressed and patient was extubated in the or/transferred to pacu in stable condition.All final counts were correct x2.Dr.(b)(6)was present for and participated in the entire procedure.Post-op procedure note: operation/procedure used was spinal fusion posterior thoracic/ lumbar 3+ levels- hardware revision, postoperative diagnosis was hardware failure of anterior column of spine.On (b)(6) 2020: neurosurgery progress assessment by dr.(b)(6) showed a patient with a past medical history of t9-ileum fusion with failed hardware admitted on (b)(6) 2019 with s/p hardware revision with replacement of bilateral loose t9 pedicle screws and extension of fusion to t8 with replacement of bilateral fractured rods.Plan- acute anemia due to blood loss (monitor with exam and treat with labs/ transfusion/ fluids as necessary); hardware failure with revision (monitor with exam and treat with surgery).On (b)(6) 2020: final results of scoliosis standing pa & lat ordered by dr.(b)(6).Indication was breakdown (mechanical) of internal fixation device of vertebrae, initial encounter.S/p hardware revision and was compared with dx spine (b)(6) 2019; dx spine (b)(6) 2018; dx spine (b)(6) 2017; cr spine (b)(6) 2017.Findings / impression showed post surgical changes of revision of posterior spinal fusion with extension of the fusion to t8 level through bilateral iliac bones.Cement is seen in the t9 vertebral body at the level of the previous screws.No change in the alignment.No immediate complications.On (b)(6) 2020: scoliosis standing pa & lat was ordered by dr.(b)(6) for the next visit.Patient was discharged by dr.(b)(6) with no medical complications.Condition on discharge- the patient was able to ambulate.He tolerated oral intake and voids without difficulty.Pain was controlled on oral medications.Patient instructions was instructed to have sutures removed 2 weeks from surgery at neurosurgery clinic or local physician's clinic.Follow-up with dr.(b)(6) in 6 weeks with scoliosis films.On (b)(6) 2020: appointment that has been made to see nurse practitioner, for hospital follow- up and suture removal.On (b)(6) 2020: follow- up of spinal fusion instrumentation (post- op visit)- history of present illness: the patient was post-status t9 to ilium fusion with l3 to s1 interbody grafting on (b)(6) 2019.He was found to have a broken rod.This had been repaired surgically on (b)(6) 2019.He describes that his low back pain is better, but he still had significant upper back pain between the shoulder blade area.He also described numbness in his bilateral toes, hands and fingers.Assessment: the patient with a past medical history of t9-ileum fusion with failed hardware admitted on (b)(6) 2020 with s/p hardware revision with replacement of bilateral loose t9 pedicle screws and extension effusion to t8 with replacement of bilateral fractured rods.On (b)(6) 2020: final scoliosis standing pa & lat by dr.(b)(6).Indication was breakdown (mechanical) of internal fixation device of vertebrae, initial encounter.S/p hardware revision and was compared with dx spine (b)(6) 2020.Findings / impression showed that there were 7 cervical vertebrae with the right c7 cervical rib, 12 thoracic vertebrae, and 5 lumbar vertebrae.Different numbering system had been used in the past.Postsurgical changes including posterior fusion between t8 to the iliac bones.No hardware complications.Stable t10 vertebral body cement.Stable anterior fusion of c3-c6.Stable alignment and curvature.On (b)(6) 2020: follow-up revision of spinal fusion instrumentation by dr.(b)(6).Assessment and plan: patient underwent revision of the thoracolumbar spine instrumentation.His low back pain is getting better, but he still has pain in his upper back.We will refer him to the pain clinic to control the upper back pain.We can increase lifting limitation to 40 lbs.Also, muscle relaxant can be adjusted according to the patient and the pcp¿s assessment.We will see him back in 3-months-time with scoliosis films.No further complications were reported/ anticipated.

Manufacturer Narrative

Additional information was provided.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.

Event Description

On (b)(6), 2017: dr.(b)(6) saw the patient for a medication refill.The patient had elevated blood pressure, gastroesophageal reflux, back pain- new> 28 days, and cough.Assessment/ plan: essential hypertension, chronic back pain, unspecified back location, unspecified back pain laterality, chronic obstructive pulmonary disease, unspecified copd type (hcc), tobacco use disorder, gastroesophageal reflux disease, esophagitis presence not specified.Patient was asked to return in about 6 months (around (b)(6) 2017).On (b)(6), 2017: dr.(b)(6) ordered a scoliosis standing pa & lat from the radiology lab to evaluate for scoliosis.This was compared with an external ct dated (b)(6), 2017.Findings/ impression- cervical acdf hardware present without complication.There is 19 degrees of levoscoliosis measured from superior endplate of l2 to the inferior endplate of l4.Stable multilevel degenerative changes as described on prior ct.On (b)(6), 2017: chest ap/ pa was ordered by dr.(b)(6).Clinical indication: status post spinal fusion.Evaluation of fluid status.Comparison: chest radiographs (b)(6) 2017.Findings: the endotracheal tube terminates just below the thoracic inlet about 10 cm superior to the carina.The lungs are hyperaerated consistent with emphysematous changes.There is no large area of focal consolidation.The pulmonary vasculature does not appear congested.No pneumothorax or evident pleural effusion.Enteric tube terminates in the gaseously distended stomach.Postsurgical changes of lower thoracic to sacral spinal fusion with surgical drain and skin staples in place.Partially visualized cervical spinal fusion hardware.Impression: 1.Interval retraction of the endotracheal tube which now terminates just below the thoracic inlet.This could be safely advanced about 5 cm.2.Interval increased gaseous distention of the stomach.The enteric tube courses inferior to the diaphragm.3.No pulmonary vascular congestion.On (b)(6), 2018: nurse practitioner (b)(6) reviewed patient progress.Hpi patient presented today to establish care with a new provider.Current concerns: chronic bilateral low back pain without sciatica: patient notes he had ongoing issues with lower back pain.Patient had spinal fusion done on (b)(6) 2017 and noted that he was having improvement until he recently heard a "pop" in his back and had increasing pain again.No specific accident or injury.The problem occurred intermittently.The problem had been gradually improving since onset.The pain was present in the lumbar spine.The quality of the pain was described as aching.The pain was moderate.The symptoms were aggravated by position.Pertinent negatives included no abdominal pain, bladder incontinence, bowel incontinence, chest pain, dysuria, fever, headaches, numbness, paresthesias, perianal numbness or weakness.He had tried analgesics and muscle relaxant for the symptoms.The treatment provided moderate relief.Patient noted that he had a current appointment to be seen with his previous surgeon on (b)(6) 2018.Patient requested one refill of his medication while waiting for this appointment.Patient was doing well without current copd symptoms.The patient denied any associated symptoms.Patient was taking his copd medications correctly.Patient reported reported no abdominal pain, chest pain, coughing, dysphagia, hoarse voice, sore throat or wheezing.Patient's hypertension was currently being treated with diet, lifestyle modification and medication.Patient expressed concerns with fatigue, weakness and lump under right armpit and umbilical area.Assessment: chronic bilateral low back pain without sciatica, chronic obstructive pulmonary disease, unspecified copd type (hcc), gastroesophageal reflux disease, esophagitis presence not specified, essential hypertension, chronic fatigue, weakness, lump in armpit, right, abdominal lymphadenopathy.Follow-up in 6 months for follow-up on chronic conditions or sooner if needed and/or dependent upon lab or ultrasound results.On (b)(6), 2018: nurse practitioner (b)(6) reviewed patient progress.Hpi patient presented today for concerns of anxiety and to go over recent lab work.Onset of anxiety and insomnia and elevated vitamin b12 level.Assessment: anxiety, insomnia, unspecified type.On (b)(6), 2018: nurse practitioner (b)(6) conducted a medical wellness exam.Approximately 1 month ago at our last visit we had started patient on medication for issues with ongoing anxiety.Patient noted that after starting medication he had concerns of mouth and tongue numbness and so abruptly stopped taking it; chronic bilateral lower back pain; advised patient to stop taking vitamin b12; patient also noted that he would like a refill today of his medications for hypertension, acid reflux, insomnia, and ibuprofen for chronic back pain.On (b)(6), 2018: nurse practitioner (b)(6) reviewed patient progress.Hpi patient presented today for follow-up on anxiety and insomnia as well as concerns of ongoing fatigue.Patient also noted that he needs a refill on his inhaler.Patient had surgery with general surgeon on (b)(6) 2018 to repair and epigastric hernia.Ct of the abdomen and pelvis was completed before the surgery.On (b)(6), 2019: nurse practitioner (b)(6) reviewed patient progress.Hpi patient presented for six-month follow-up on chronic conditions as well as a few other concerns.Assessment: essential hypertension, weakness, lightheadedness, dizziness, thoracic aortic aneurysm without rupture (hcc), chronic obstructive pulmonary disease, unspecified copd type (hcc), gastroesophageal reflux disease without esophagitis.On (b)(6), 2019: nurse practitioner (b)(6) reviewed patient progress.Hpi patient presented for follow-up on hospitalization for copd exacerbation and pneumonia.Patient was also requesting a refill of his blood pressure medication.Assessment: hospital discharge follow-up, copd with acute exacerbation (hcc), and essential hypertension.Patient stated that he was feeling better at this time and had no current concerns or complaints.He noted that he would be having a follow-up appointment with his pulmonologist for follow-up of copd exacerbation and follow-up of a 7mm nodule found in his right lung.Patient stated that he had an echocardiogram scheduled for tomorrow and that he will have a follow-up appointment with his cardiologist as they will also be having him complete a stress test and wear a holter monitor.Follow-up as needed.On (b)(6), 2019: nurse practitioner (b)(6) reviewed patient progress.Hpi patient presented to discuss issues with anxiety and chronic bilateral low back pain.Assessment: anxiety, chronic bilateral low back pain without sciatica, controlled substance agreement signed.Follow-up in 1 month for medications.On (b)(6), 2019: nurse practitioner (b)(6) reviewed patient progress.Hpi patient presented for one-month follow-up on anxiety medication and chronic back pain medication.Assessment: chronic bilateral low back pain without sciatica, anxiety.Follow-up in 6 months for chronic conditions or sooner if needed.On (b)(6), 2019: nurse practitioner (b)(6) conducted a medical wellness exam.Patient had additional complaints unrelated to their medicare wellness (ippe/awv) evaluation today.Please see additional notes in this encounter for details.Patient also presented for follow-up in 6-month follow-up on chronic conditions.Assessment: medicare annual wellness visit, subsequent; essential hypertension; chronic obstructive pulmonary disease, unspecified copd type (hcc); chronic bilateral low back pain without sciatica; s/p spinal fusion; anxiety; controlled substance agreement signed; vitamin b12 deficiency.Follow-up in 3 months for med check.Follow up recommended in 1 year for annual wellness visit, sooner as needed for any new medical concerns or as advised for management of chronic medical conditions.On (b)(6), 2020: nurse practitioner (b)(6) reviewed patient progress.Hpi patient presented for 6-month follow-up on chronic conditions as well as follow-up of recent surgery and to request a referral to the local pain clinic.Assessment: s/p spinal fusion; chronic bilateral low back pain without sciatica; chronic bilateral thoracic back pain; essential hypertension; gastroesophageal reflux disease, esophagitis presence not specified; chronic obstructive pulmonary disease, unspecified copd type (hcc); thoracic aortic aneurysm without rupture (hcc); anxiety.Follow-up in 3 months for follow-up on anxiety medication and to follow-up on status of referral to pain clinic.On (b)(6), 2020: dr.(b)(6) ordered a scoliosis standing pa & lat from the radiology lab to for arthrodesis status and s/p lumbar revision.It was compared to dx spine from (b)(6) 2020.Findings / impression: stable postsurgical changes of thoracolumbar posterior spinal fusion with interbody spacer placement at l2-l3, l4-l5 and ls-s1.No evidence of hardware complications.Alignment is unchanged from prior exam.Incidentally noted postprocedural changes of kyphoplasty within the mid thoracic spine.Postsurgical changes of lower cervical spine acdf.On (b)(6), 2020: nurse practitioner (b)(6) reviewed patient progress.Hpi patient presented for follow-up on chronic conditions via telephone visit due to the current coronavirus situation.Assessment: assessment/orders: s/p spinal fusion; chronic bilateral low back pain without sciatica; gastroesophageal reflux disease, esophagitis presence not specified; essential hypertension; thoracic aortic aneurysm without rupture (hcc); chronic obstructive pulmonary disease, unspecified copd type (hcc); low testosterone; anxiety; other insomnia; restless leg syndrome.Advised patient that we will follow-up again in 3 months for follow-up on chronic conditions and blood pressure and patient verbalized understanding and was in agreement with this plan of care.On (b)(6), 2020: dr.(b)(6) ordered and mri spine cervical without contrast for cervicalgia, evaluate n/t, neck pain indication.Technique used was multisequence, multiplanar mri of the cervical spine without iv contrast.Exam was performed using a degenerative protocol.It was compared to dx spine (b)(6) 2020; ct spine (b)(6) 2019.Findings showed that there was normal alignment without evidence of acute fracture or dislocation.Post-surgical changes of c3-c6 anterior spinal fusion better evaluated on prior radiographs.Vertebral body heights are well-maintained.The visualized cord is within normal limits.Normal marrow signal throughout.Prevertebral structures are unremarkable.A level by level analysis is as follows- c2-c3 [broad-based central disc herniation with mild thecal sac effacement, no significant neural foraminal stenosis]; c3-c4 [small broad-based central disc herniation with mild thecal sac stenosis, no significant neural foraminal stenosis]; c4-c5 [small broad-based disc herniation with mild thecal sac stenosis, no significant neural foraminal stenosis]; c5-c6 [small right paracentral disc herniation with osteophytes and ligamentum flavum thickening causing mild thecal sac stenosis, moderate bilateral neural foraminal stenosis]; c6-c7 [broad-based central disc herniation, promi nent ligamentum flavum thickening and foraminal osteophytes causing moderate thecal sac narrowing, moderate bilateral neural foraminal stenosis; c7-t1 [there is no significant disc disease or stenosis.] impression: status post c3-c6 acdf, multilevel degenerative c hanges, most significantly at c5-c6 and c6-c7 as described.No abnormal spinal cord signal to suggest myelopathy.Dr.(b)(6) ordered and mri spine cervical without contrast for pain in thoracic spine, evaluate thoracic pain indication.Technique used was multisequence, multiplanar mri of the cervical spine without iv contrast using a degenerative disease protocol.It was compared to dx spine (b)(6) 2020; ct spine (b)(6) 2019; mr spine (b)(6) 2007.Findings showed suboptimal evaluation of distal thoracic spine secondary to extensive metallic artifact.Redemonstrations of postsurgical changes of posterior spinal fusion of the distal thoracic spine beginning with level t9 with redemonstration of t9 anterior less of vertebral body height which was noted on prior plain films dated (b)(6) 2020 but is new compared to cross sectional imaging dated (b)(6) 2019.There is, otherwise, normal alignment without evidence of acute fracture or dislocation.Vertebral body heights are, otherwise, well-maintained.There is no significant effacement of the thecal sac or neural foraminal stenosis.Visualized cord is within normal limits.Normal marrow signal.Paravertebral soft tissues are unremarkable.Impression: 1.Stable postoperative changes of distal thoracic spine fusion with redemonstration of anterior loss of vertebral body height of t9 which is stable compared to plain films dated (b)(6) 2020 but is new compared to cross sectional imaging dated (b)(6) 2019.2.No significant effacement of the thecal sac or neural foraminal stenosis.Dr (b)(6) ordered a scoliosis standing pa & lat for an arthrodesis status, evaluate hardware indication.It was compared to dx spine (b)(6) 2020; dx spine (b)(6) 2020; dx spine (b)(6) 2020; cr spine (b)(6) 2017.Findings/ impression: stable postsurgical changes including t8 to iliac bone posterior spinal fusion with interbody spacer l2-l3, l4-l5, and l5-s1.No evidence of internal hardware complication.Stable alignment.Stable post procedural changes of t9 kyphoplasty.Stable acdf of the lower cervical spine.Hyperexpanded bilateral lungs with flattening of the diaphragm consistent with the patient¿s known clinical history of chronic obstructive pulmonary disease.On (b)(6), 2020: dr.(b)(6) ordered ct lumbar spine without contrast for arthrodesis status, evaluate hardware indication.Technique used was axial ct of lumbar spine without iv contrast.Sagittal and coronal reformations are also provided for review.It was compared to mr t spine (b)(6) 2020; ct spine (b)(6) 2019.Findings: there are 5 lumbar type vertebral segments with transitional l5 anatomy.Levocurvature of the lumbar spine.The spine is visualized from the t12-s2 level.Prior laminectomy at l3-l5.There is posterior fixation hardware bilaterally seen at the t12-s1 levels with bilateral iliac screws.The hardware extends upwards outside the field of view.There is no evidence of hardware fracture.Lucency about the right l4, bilateral s1, and possibly portions of the iliac screws.Interbody spacers at the l2-l3, l4-l5, and l5-s1 levels appear unchanged.Redemonstration of levocurvature of the lumbar spine centered at the l2 level.There is moderate to severe degenerative disease including a decrease in intervertebral disc height as well as endplate spurring.Grade 1 retrolisthesis of l1 on l2 without change.There is prominent artherosclerotic plaquing of the infrarenal abdominal aorta with fusiform aneurysmal dilation of the distal aorta measuring up to 3.3cm.The imaged intrapelvic and intra-abdominal content is without acute abnormality.No prevertebral fluid collections or mass.Impression: 1.5 lumbar type vertebrae with transitional morphology of l5.2.Lucencies about the right l4, bilateral s1, and possibly parts of the iliac screws.2.Partially visualized thoracic to iliac bone posterior spinal fusion.4.Fusiform abdominal aortic aneurysm measuring up to 3.3cm.On (b)(6), 2020: dr.(b)(6) ordered a l spine ap & lateral and t spine ap & lateral from radiology for arthrodesis status, f/u fusion revision indication.It was compared to ct spine (b)(6) 2020.Findings/ impression: posterior fusion from t8 through the sacrum.Interbody spacers noted at l2-3, l4-5, and l5-s1.No evidence of hardware complication.Alignment appears minimally improved.Overlying staples noted.On (b)(6), 2020: dr.(b)(6) ordered scoliosis standing pa & lat from radiology for arthrodesis status, f/u fusion hardware revision t8-pelvis indication.It was compared to cr spine (b)(6) 2020; cr spine (b)(6) 2020; dx spine (b)(6) 2020; dx spine (b)(6) 2020; dx spine (b)(6) 2020; cr spine (b)(6) 2017.Findings/ impression: postoperative changes of t8 to ilium posterior spinal fusion and disc spacers at l2-l3, l$-l5, and l5-s1.Status post kyphoplasty changes of t9.Postoperative changes of c3-c7 anterior spinal fusion skipping c4.Coronal balance is within normal limits, sagittal balance is 5.0cm forward.On (b)(6), 2020: post hospital follow up by nurse practitioner (b)(6).Primary diagnosis: s/p lumbar fusion.Assessment: hospital discharge follow-up, s/p spinal fusion.Treatment plan and follow up was reviewed and understood by the patient.Patient was instructed to call for questions, concerns or changes in condition.On (b)(6), 2020: nurse practitioner (b)(6) reviewed progress notes.Hpi patient presented for surgical staple removal as he was s/p lumbar fusion 10 days ago.Assessment: encounter for staple removal, s/p spinal fusion.Follow-up as needed.On (b)(6), 2020: dr.(b)(6)ordered a scoliosis stand pa & lat from radiology for arthrodesis status, s/p lumbar revision indication.It was compared to dx spine (b)(6) 2020; cr spine (b)(6) 2020; cr spine (b)(6) 2020.Findings/ impression: stable postsurgical changes of t8 to the ileum posterior spinal fusion and l2-l3, l4-l5, l5-s1 disc spacers.Postoperative changes of cervical spine acdf.2.9cm of forward sagittal balance and 2.8cm of right coronal balance.On (b)(6), 2020: dr.(b)(6) ordered ct thoracic and lumbar spine without contrast for arthrodesis status, pre-op for revision for indication.Technique used was axial ct images of the thoracic and lumbar spine were obtained from c7-t1 to s1-s2 disc space without administration of iv contrast.Coronal and sagittal reformatted images were generated reviewed.It was compared to ct spine (b)(6) 2020.Findings showed that postsurgical changes of t8-ilium posterior spinal fusion.The osseous structures are normal in alignment.There is no evidence of fracture.Vertebral body heights and intervertebral disc heights are well maintained.Spinal canal is normal.Visualized lungs show bilateral emphysematous changes.Perivertebral soft tissues are normal.Thyroid is grossly normal [t-spine].Postsurgical changes of t8-ilium posterior spinal fusion.Interbody spacers of l2-l3, l4-l5, and l5-s1.Upon review, the scoliosis radiograph dated (b)(6) 2020 shows the left rather fracture at the level of l4-l5.It is difficult to visualize on today¿s exam, but there is a faint fracture line seen.Levocurvature of the lumbar spine.Stable mild retrolisthesis of l1 on l2.There is no e vidence of fracture.Vertebral body heights and intervertebral disc heights are well maintained.Spinal canal is normal perivertebral soft tissues are normal.Atherosclerotic calcifications of the fusiform aneurysmal abdominal aorta measuring approximately 3.4cm, grossly stable from prior ct lumbar spine dated 7/23.2020 [l-spine].Impression: 1.Postsurgical changes of t8-ilium posterior spinal fusion with left rod fracture at the level of l4-l5.2.Stable fusiform infrarenal abdominal aortic aneurysm measuring 3.4cm.Dr.Mark.C.Dougherty ordered a ct thoracic & lumbar spine without contrast for arthrodesis status, follow up thoracic/ lumbar fusion revision, ensure no hardware complications indication.Technique used axial ct images of the thoracic and lumbar spine were obtained from c7-t1 to s1-s2 disc space without administration of intravenous contrast.Coronal and sagittal reformatted images were generated images.It was compared to ct spine (b)(6) 2020; ct spine (b)(6) 2020.Findings: interval postsurgical changes including replacement of left t8 and s1 pedicular screw and placement of allograft at t8-t9 and l1-ilium.Right t8 pedicular screw fracture is more apparent.Drain in place.Surgical staples in place.Otherwise similar postsurgical changes including t8-iliac bone posterior spinal fusion.Vertebral body heights and remainder of exam are similar to prior.Impression: 1.Interval postsurgical changes including replacement of left t8 and s1 pedicular screws and placement of allograft at t8-t9 and l1-ilium.2.Right t8 pedicular screw fracture is more apparent.3.Otherwise similar postsurgical changes including t8-iliac bone posterior spinal fusion.On (b)(6), 2020: dr.(b)(6) ordered a scoliosis standing pa & lat from radiology for arthrodesis status, follow up fusion revision, rule out hardware complication indication.It was compared to ct spine (b)(6) 2020; ct spine (b)(6) 2019.Findings/ impression: there are 7 cervical, 12 thoracic, and 5 lumbar type vertebrae.There are cervical ribs at c7.A transitional morphology of l5.Similar alignment.Similar vertebral body height loss most apparent at t8.Recent revision of t8-iliac bone posterior spinal fusion including replacement of a rod, left t8 and s1 pedicular screws and placement of allograft t8-t9 and l1-ilium.Similar right t8 pedicular screw fracture.Otherwise, no internal hardware complication.Surgical staples in place.On (b)(6) 2020: dr.(b)(6) reviewed progress notes.The patient was here for hospital f/u ((b)(6)).The patient presented to the clinic for discussion of his hospital stay.He had another back surgery at the on (b)(6) 2020 and then he went to genesis for rehab.He has been having a lot of pain still.He has not started his physical therapy yet.He has no radiation of the pain down into his legs.He denies any bowel or bladder control loss.He has run out of his pain medicine.He has no other complaints.Assessment: chronic bilateral low back pain without sciatica.On (b)(6), 2020: dr.(b)(6) ordered scoliosis standing pa & lat from radiology for arthrodesis status, t8-ilium hardware revision indication.It was compared to dx spine (b)(6) 2020; dx spine (b)(6) 2020; dx spine (b)(6) 2020; cr spine (b)(6) 2020; cr spine (b)(6) 2020; cr spine (b)(6) 2017.Findings/ impression: t8 to sacrum/ ilium revision posterior spinal instrumentation and decompression is unchanged in appearance and alignment.There is an allograft/ cement at t9 body, and of l1 through ileum.Internal fusion l1-l2, l3-l4, l4-l5.Similar t8 pedicle screw fracture, likely right.Internal removal of surgical staples.C3-c7 anterior cervical fusion visualized.On (b)(6), 2020: nurse practitioner (b)(6) reviewed progress notes.Hpi patient presented for follow-up on chronic conditions and to discuss ongoing issues with back pain.Dr.(b)(6) mentioned that the patient has a very complex spinal surgical history which began with a t8 to ilium fusion by his team in (b)(6) 2017, which later required hardware revision in (b)(6) 2019 due to rod breakage, and subsequently he had a recurrent right rod breakage for which he underwent another revision surgery (b)(6) 2020, and at his postoperative follow-up visit after that, a left sided rod breakage was discovered and therefore, he underwent left-sided rod revision on (b)(6) 2020.Notably during each of these 2 most recent surgeries, the s1 screw was found to be loose on the operated side and so the s1 screw was replaced each time.He returned for his routine 6-week follow-up after his most recent left-sided rod revision surgery.Patient noted that his next follow-up visit with neurosurgery is scheduled for (b)(6) 2020.He states that he is still having pain and that they are insisting at this time there are no further concerns with his hardware.Patient is also continuing physical therapy sessions.Follow-up again in 3 months for follow-up on pain medication.On (b)(6), 2021: nurse practitioner (b)(6) reviews medicare wellness visit.Patient states today that after having his last revision he is actually starting to feel significantly better and feels like we could see about working on weaning him down off of the pain medication.Patient states he is starting to work out very lightly to build up his strength.He is also continuing physical therapy sessions.He reports no problems at this time with abdominal pain, chest pain, coughing, dysphagia, hoarse voice, sore throat or wheezing.Follow up recommended in 1 year.

Manufacturer Narrative

B5: additional info updated medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

B5, b6, b7: additional event details updated medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2020: patient was admitted.Patient had inpatient consult- uihc physical therapy and inpatient consult- occupational therapy to evaluate and treat patient ordered by dr.Mark.C.Dougherty.Dr.Mark.C.Dougherty ordered scoliosis standing pa <(>&<)> lat for follow up fusion hardware revision t8-pelvis.Post op assessment: patient with pmh of t8-ilium fusion in 2017 with prior revision on (b)(6) 2019 due to loose screws in sacrum and ilium, who was found to have loose right s1 screw and rod displacement from r iliac screw s/p r s1 screw replacement and re-connection of existing iliac screw to rod on the right side on (b)(6) 2020.Post op procedure note: pre-op and post-op diagnosis was s/p lumbar fusion <(>&<)> failure of hardware at s1 and ilium (right sided only) from prior t8-ilium instrumented fusion, procedure performed- hardware revision, right side, with replacement of right s1 screw (new screw: 8.5mm x 40mm, with bone cement placed into screw hole prior to placement of screw) and re-attachment of rod to iliac screw.Use of intraoperative fluoroscopy and personal interpretation of images.Patient was flipped onto the operating room table in the prone position with the arms abducted at the shoulder.Once all the screws and the full length of the rod were exposed on the right side, all of the setscrews were removed and these were discarded.The rod was subsequently removed.Also, the right iliac screw set screw had fallen out, as noted on preoperative images.This right iliac setscrew was also retrieved and discarded.The right s1 screw was pulled out easily as it was significantly loosened from the underlying bone and not attached securely.Thus, bone cement was injected into the screw hole on the right side at s1 and subsequently an 8.5 mm x 40 mm screw was placed into the right s1 pedicle.The previous screw had been a 7.5 mm x 35 mm screw, hence the upsizing was felt to be necessary to be securely placed.Once the bone cement had adequately hardened, we replaced the existing rod onto the screws and use new set screws to secure it into place at all levels.Ap and lateral fluoroscopy were used to confirm the placement of the hardware.We then decorticated the bone at l5 and s1 in order to facilitate bony fusion on the right side.There were no intraoperative complications noted.On (b)(6) 2020: neurosurgery progress note by dr.Oya- vitals were stable.Dressing had to be changed overnight but is now clean.Still need to work on pain control.Drain removed.Patient was scheduled for rehab physical therapy with amy.S.Little (physical therapist).Assessment: doctor removed wound drain prior to pt.Patient is willing to work with physical therapy today.Notes he has increased pain with pressure on his incisions.Patient is postop day 1 revision for spinal fusion.He is able to ambulate safely, has good standing balance.He is likely ready for discharge to home when medically ready.On august 24, 2020: dr.Mark.C.Dougherty scheduled a pcp follow up for staple removal and medical checkup after surgery (if needed).He also scheduled a neurosurgery follow up for fusion revision in 6 weeks.Patient was discharged to self/ home care after scoliosis films.Patient was scheduled to follow up in 2 weeks with (b)(6) on (b)(6) 2020.Patient was scheduled for rehab therapy occupational with brianne duncan (occupational therapist).Patient was discharged by taylor.M.Suchan (nurse) and given discharge instructions and verbalized understanding.Neurosurgery progress notes by (b)(6) patient still having intermittent hand symptoms, however advised that we expect this to improve with time as not relatable to surgery.Operations/procedures performed: spinal fusion hardware revision, right side, with replacement of right s1 screw (new screw: 8.5mm x 40mm, with bone cement placed into screw hole prior to placement of screw) and re-attachment of rod to iliac screw.Hospital course: his pain was managed and he was able to be weaned off of iv narcotic medication postoperatively and onto oral only medication for pain control.A surgical drain was kept in place until the output dropped below 50 cc per 8-hour shift at which point it was removed.He was kept on postoperative prophylactic antibiotics for greater than 24 hours and as long as the drain was in.Postoperatively his neurological status remained intact.On postoperative day 1, he was evaluated by physical therapy and was cleared for discharge home.On postoperative day 2, he had standing thoracic and lumbar spine films and these demonstrated good results from the surgical hardware revision.On the morning of postoperative day 3 he was discharged after having his standing scoliosis films completed.Results for scoliosis standing pa <(>&<)> lat by dr.Mark.C.Dougherty- indication: arthrodesis status, follow up fusion hardware revision t8-pelvis; comparison: cr spine (b)(6) 2020;cr spine (b)(6) 2020;dx spine (b)(6) 2020;dx spine (b)(6) 2020;dx spine (b)(6) 2020;cr spine (b)(6) 2017; findings / impression: postoperative changes of t8 to ilium posterior spinal fusion and disc spacers at l2-l3, l4-l5 and l5-s1.Status post kyphoplasty changes of t9.Postoperative changes of c3-c7 anterior spinal fusion skipping c4.Coronal balance is within normal limits, sagittal balance is 5.0cm forward.Disposition: home, outpatient physical therapy.Patient was given instructions.Stitches/staples are to be removed 2 weeks after surgery at uihc or local provider.Follow-up for suture/staple removal 14 days after your surgery with your local doctor.Follow-up with (b)(6) in 6 weeks with scoliosis films.(b)(6) scheduled a neurosurgery follow up fusion revision in 6 weeks.On (b)(6) 2020: patient was referred to (b)(6) groth in the neurology clinic for evaluation of dizziness.Operat ions/procedures performed: 1.Removal of prior bilateral rods and bilateral t9 pedicle screws 2.Placement of bilateral t8 and t9 pedicle screws, use of cement in t9 fenestrated screws 3.Placement of bilateral new rods 4.Bilateral laminectomy and decompression at t9/t10 5.8/4/2020: spinal fusion hardware revision of t8-ilium.Assessment- patient describes this dizziness as a 'brain fog' and a 'head rush', unclear if vertiginous or not.He has had a comprehensive workup for the same (b)(6) ordered a non-uihc consult pt/ot.Assessment- pmh of t8-ilium fusion in 2017 with prior revision on 12/30/2019 due to loose screws in sacrum and ilium who was found to have loose right s1 screw and rod displacement from r iliac screw s/p r s1 screw replacement and re-connection of existing iliac screw to rod on the right side on 8/21/2020.Pt diagnosis: back pain, difficulty walking patient's primary goal: decrease back pain.On (b)(6) 2020: (b)(6) same day admitted the patient for revision of left sided hardware, possible right side also, with replacement of rod and reinforcement.C-arm, osi bed, possible o-arm.(b)(6) ordered a ct thoracic and lumbar spine without contrast for revision pre-op.Dr.Mark.C.Dougherty scheduled a fluoro c arm for intra-op positioning.Patient visited dr.Oya in neurosurgery clinic for follow-up 6 weeks right sided hardware revision.Patient has past medical history of a t8 to ilium fusion and has required revisions in the past, most recently now a right-sided revision due to pull out of a setscrew in the iliac screw, and looseness of the right s1 screws, so the right s1 screw was replaced and the rod was placed back into all of the screw heads and resecured.He discharged after 2 days in the hospital to home with physical therapy ordered as an outpatient.He says that he feels like the right sided rod is sticking out, not in any particular area but along the entire length of the rod.He says that he cannot lean on a hard surface because of this.He states that immediately after the staples were removed from his incision there was a little bit of drainage but that has resolved completely.He is still having stabbing pain in his back.Neurologist has set him up for an evaluation in the movement disorder clinic due to his odd movements concerning for huntington's disease.He will be evaluated for possible huntington's disease diagnosis 10/16/2020.Assessment: patient presented with 6-week follow-up for right-sided hardware revision, and clinically speaking he appears to be doing well but his imaging is concerning for now a left-sided rod breakage between l4 and l5.On retrospective review, this was actually present although not noted by visiting surgical team or the radiology team on the scans that were taken immediately postop on (b)(6).This breakage was not present on the ct scan on (b)(6).This rod breakage also is not clearly visualized on the intraoperative fluoroscopy images are saved into the pacs system, although admittedly this visualization is less than ideal and not focused on that area.Ultimately is not clear exactly what happened, but may have happened immediately after the surgery or during the surgery or any interval between the ct and the follow up scan.Ultimately, because of this the patient is indicated for left-sided hardware revision.Given the rod breakage there is also suggestion of pseudoarthrosis.We will thus plan to perform both a hardware revision, place any potential loose screws, replaced the entire rod with a new rod, likely use a second parallel rod to be connected via wedding band connections in order to provide extra axial strength, and to repeat the bony fusion posterior lateral fusion using osteo-amp allograft and likely also bone morphogenetic protein (bmp).This was explained to the patient and he has consented to the procedure.The risks, benefits, and alternatives have been appropriately discussed and an informed consent obtained.Plan: plan for left sided thoraco-lumbo-sacral hardware revision and revision of fusion with allograft and bmp, possible right sided hardware revision (only if necessary) as well, and possible o-arm intraoperative ct scan, ct scan preop to rule out any other possible hardware complications.Dr.Oya ordered ct thoracic and lumbar spine without contrast for revision pre-op.On (b)(6) 2020: nurse (b)(6) gave preoperative/ education to the patient.Preoperative screenings completed.Scheduled for revision of hardware with (b)(6).Work up completed on (b)(6).Will have ct on (b)(6) at 0700.Reviewed patient's current medications and instructed patient on medications that can be taken prior to surgery.(b)(6) ordered ct thoracic and lumbar spine without contrast for arthrodesis status.Pre op for revision.Technique: axial ct images of the thoracic and lumbar spine were obtained from c7-t1 to s1-s2 disc space without administration of intravenous contrast.Coronal and sagittal reformatted images were generated reviewed.It was compared to ct spine 7/23/2020.Findings: postsurgical changes of t8-ilium posterior spinal fusion.The osseous structures are normal in alignment.There is no evidence of fracture.Vertebral body heights and intervertebral disc heights are well maintained.Spinal canal is normal.Visualized lungs show bilateral emphysematous changes.Perivertebral soft tissues are nor mal.Thyroid is grossly normal.[t spine] postsurgical changes of t8-ilium posterior spinal fusion.Interbody spacers of l2-l3, l4-l5, and l5-s1.Upon review, the scoliosis radiograph dated 10/08/2020 shows the left rather fracture at the level of l4-l5.It is difficult to visualize on today's exam, but there is a faint fracture line seen.Levocurvature of the lumbar spine.Stable mild retrolisthesis of l1 on l2.There is no evidence of fracture.Vertebral body heights and intervertebral disc heights are well maintained.Spinal canal is normal.Perivertebral soft tissues are normal.Atherosclerotic calcifications of the fusiform aneurysmal abdominal aorta measuring approximately 3.4 cm, grossly stable from prior ct lumbar spine dated (b)(6) 2020.[l spine] impression: 1.Postsurgical changes of t8-ilium posterior spinal fusion with left rod fracture at the level of l4-l5.2.Stable fusiform infrarenal abdominal aortic aneurysm measuring 3.4 cm.(b)(6) scheduled an inpatient physical therapy and occupational therapy consult to evaluate (b)(6) (b)(6) ordered a ct thoracic and lumbar spine without contrast for arthrodesis, follow up thoracic/lumbar fusion revision, to ensure no hardware complications.Technique: axial ct image s of the thoracic and lumbar spine were obtained from c7-t1 to s1-s2 disc space without administration of intravenous contrast.Coronal and sagittal reformatted images were generated reviewed.It was compared to ct spine (b)(6) 2020;ct spine (b)(6) 2020.Findings: interval postsurgical changes including replacement of left t8 and s1 pedicular screw and placement of allograft at t8-t9 and l1-ilium.Right t8 pedicular screw fracture is more apparent.Drain in place.Surgical staples in place.Otherwise similar postsurgical changes including t8-iliac bone posterior spinal fusion.Vertebral body heights and remainder of exam are similar to prior.Impression: 1.Interval postsurgical changes including replacement of left t8 and s1 pedicular screws and placement of allograft at t8-t9 and l1-ilium.2.Right t8 pedicular screw fracture is more apparent.3.Otherwise similar postsurgical changes including t8-iliac bone posterior spinal fusion.Dr.Mark.C.Dougherty ordered a scoliosis standing pa <(>&<)> lat to follow up on fusion revision, to rule out hardware complication [comparison: ct spine (b)(6) 2020;ct spine (b)(6) 2019; findings / impression: there are 7 cervical, 12 thoracic and 5 lumbar type vertebrae.There are cervical ribs at c7.A transitional morphology of l5.Similar alignment.Similar vertebral body height loss most apparent at t8.Recent revision of t8 - iliac bone posterior spinal fusion including replacement of a rod, left t8 and s1 pedicular screws and placement of allograft at t8-t9 and l1-ilium.Similar right t8 pedicular screw fracture.Otherwise no interval hardware complication.Surgical staples in place.] nurse practitioner laura langholdt scheduled a scoliosis standing pa<(>&<)> lat (t8-ilium hardware revision).Dr.Mark.C.Dougherty did an interval history and physical.Chief complaint was follow-up 6 weeks right sided hardware revision.History of present illness- patient had past medical history of a t8 to ilium fusion and ha s required revisions in the past, most recently now a right-sided revision due to pull out of a setscrew in the iliac screw, and looseness of the right s1 screws, so the right s1 screw was replaced and the rod was placed back into all of the screw heads and resecured.He discharged after 2 days in the hospital to home with physical therapy ordered as an outpatient.He says that he feels like the right sided rod is sticking out, not in any particular area but along the entire length of the rod.He says that he cannot lean on a hard surface because of this.He states that immediately after the staples were removed from his incision there was a little bit of drainage but that has resolved completely.He is still having stabbing pain in his back and has tried and failed to get into a pain clinic appointment to evaluate this.He also notably has been seen by the neurologist here at uihc and they have set him up for an evaluation in the movement disorder clinic due to his odd movements concerning for huntington's disease.He will be evaluated for possible huntington's disease diagnosis (b)(6) 2020.Assessment: patient presented with 6-week follow-up for right-sided hardware r evision, and clinically speaking he appears to be doing well but his imaging is concerning for now a left-sided rod breakage between l4 and l5.On retrospective review, this was actually present although not noted by visiting surgical team or the radiology team on the scans that were taken immediately postop on (b)(6).This breakage was not present on the ct scan on (b)(6).This rod breakage also is not clearly visualized on the intraoperative fluoroscopy images are saved into the pacs system, although admittedly this visualization is less than ideal and not focused on that area.Ultimately is not clear exactly what happened but may have happened immediately after the surgery or during the surgery or any interval between the ct and the follow up scan.Ultimately, because of this the patient is indicated for left-sided hardware revision.Given the rod breakage there is also suggestion of pseudoarthrosis.We will thus plan to perform both a hardware revision, place any potential loose screws, replaced the entire rod with a new rod, likely use a second parallel rod to be connected via wedding band connections in order to provide extra axial strength, and to repeat the bony fusion posterior lateral fusion using osteo-amp allograft and likely also bone morphogenetic protein (bmp).This was explained to the patient and he has consented to the procedure.The risks, benefits, and alternatives have been appropriately discussed and an informed consent obtained.Plan for left sided thoraco-lumbo-sacral hardware revision and revision of fusion with allograft and bmp, possible right sided hardware revision (only if necessary) as well, and possible o-arm intraoperative ct scan.Ct scan preop to rule out any other possible hardware complications.Neurosurgery post operative check- patient with pmh of multiple prior revision surgeries, with t8-ilium hardware, who had a recent right sided t8-ilium revision for broken rod and subsequently was found to have left sided rod fracture, now s/p left hardware revision (replaced rod and replaced t8 and s1 screws on left because were loose) and redo fusion with bmp/osteoamp/corticocancelous allograft on 10/16/2020.Assessment: patient with pmh of multiple prior revision surgeries, with t8-ilium hardware, who had a recent right sided t8-ilium revision for broken rod and subsequently was found to have left sided rod fracture, now s/p left hardware revision (replaced rod and replaced t8 and s1 screws on left because were loose) and redo fusion with bmp/osteoamp/corticocancelous allograft on 10/16/2020.Post-op procedure note- operation/procedure: posterior thoracic/ lumbar hardware revision with possible o-arm use; pre-op/ post-op diagnosis: s/p spinal fusion, spinal fusion hardware failure, left side; operation/procedure performed: revision of left spinal fusion hardware, t8 to ilium, with replacement of fractured left rod with new 6.0 mm diameter rod and replacement of loose left t8 and left s1 screws using new fenestrated screws with pmma bone cement.Redo posterior lateral bone fusion from t8-9 and l1 to ilium using allograft cortical cancellous bone chips, osteoamp, and bmp (levels t9-l1 were found to have good existing bony fusion).Use of intraoperative fluoroscopy and personal interpretation of images; indications: patient presented for 6-week follow-up visit of a right sided fusion hardware revision and postoperative imaging revealed a left-sided rod fracture between l4 and l5.Due to the concerns about the stability of his fusion construct he is indicated for revision of the left-sided hardware.Thoracic thyroid continues to be intact; procedure details: patient was prepped and draped in usual sterile fashion.The hardware was exposed on the left side once again from t8 to the iliac screw on the left.Upon completion of the full exposure the setscrews were removed from all of the pedicle screws and the existing fractured rod was subsequently removed.As expected, the rod was found to be fractured between l4 and l5.We then proceeded to test all of the screws and it was determined that the t8 and s1 screw were loose so these were removed.We replaced them with screws of the same size but which were fenestrated, and following placement of the new fenestrated screws, under lateral fluoroscopic guidance, we injected pmma bone cement through the inner lumen of the screws.After allowing the cement to dry, the new screws were found to be appropriately secured into the bone.It was then noted that the bony fusion was not of the excellent strength from l1 to the ileum and from t8-9.The t9-l1 area appeared well fused so this was not redone.Once the rod was appropriately shaped it was secured into the pedicle screw heads using set screws.Once this was completed ap and lateral fluoroscopy images were taken to confirm the placement of the hardware.The setscrews were then all final tightened.The bony fusion was then completed using cortical cancellous bone chips allograft, osteoamp allograft, and bmp.There were no intraoperative complications noted.On (b)(6) 2020: patient had physical therapy with (b)(6) (physical therapist).Patient with history of t8-ilium fusion with recent revision of r side hardware due to rod fx (6 weeks ago) that is s/p l hardware revision 10/16 for management of l rod fx.Patient demonstrates increased post-surgical pain, impaired motor coordination, impaired gait stability, and impulsivity in the setting of l t8-ilium hardware revision 10/16.Dr.Oya¿s neurosurgery progress notes- pain well managed but still feels tightness in back following surgery.Neuro intact exam.No other issues today am.Drain remains in.(b)(6) ordered a fluoro c- arm.On (b)(6) 2020: patient had physical therapy with (b)(6) (physical therapist).Assessment- patient demonstrated improved overall gait stability and less impulsivity today, but continues to require minimal assistance for balance during ambulation.Dr.Oya¿s neurosurgery progress notes- drain was removed.On (b)(6) 2020: (b)(6) neurosurgery progress notes- vitals stable.No new issues.Needs standing films and will get pt/ot to re-evaluate.Patient had physical therapy with (b)(6) (physical therapist).Assessment- patient with impulsivity, slurred speech, decreased balance, and dysmetric stepping during gait.Patient continues to require assistance for balance during ambulation and use of wh.Walker for safety.Patient had occupational therapy with kimberly.K.Hopwood (occupational therapist).Assessment- patient is alert and appropriate with some impulsivity in movement.He demonstrates decreased transitional movement and functional balance with basic adl/iadl.Current plan is for patient to transfer to his local inpatient rehab setting to maximize his functional recovery prior to return home.On (b)(6) 2020: patient had physical therapy with (b)(6) (physical therapist assistant).Assessment- patient continues to demonstrate some impulsivity w/ transitional movements and ambulation w/ unsteadiness and cueing for technique for safety.Dr.Oya¿s neurosurgery progress notes- vitals stable.No new issues.Has continued to state his sensation is 15-20% decreased compared to normal in his legs but this is stable vs preop and hasn't change while he's been here.Pt/ot re-evaluated yesterday and still recommend rehab.Med ready.On (b)(6) 2020: patient was discharged with pt and ot to evaluate and treat.(b)(6) neurosurgery progress notes- stable.Discharge to rehab today.Neurosurgery discharge summary- reason for admission: elective surgical procedure; primary diagnosis: hardware failure (rod breakage) of thoraco-lumbo-sacral spine instrumented fusion; operations/procedures performed: left side only hardware revision, t8-ilium, with replacement of left t8 and left s1 screws and replacement of fractured rod with new 6.0mm diameter rod; hospital course: by the time of discharge his pain was well controlled on oral medications alone.He was evaluated by pt and ot and they recommended discharge to an acute rehab facility.Postoperative ct scan and postoperative scoliosis films were obtained and demonstrated no significant complication with the hardware.Patient instructions: follow-up for suture/staple removal 14 days after your surgery with your local doctor.Follow-up with (b)(6) in 6 weeks with repeat standing scoliosis films.Nurse practitioner (b)(6) scheduled a neurosurgery follow-up with (b)(6) in 6 weeks and a scoliosis standing pa <(>&<)> lat for arthrodesis status, t8-ilium hardware revision [results on (b)(6) 2020- comparison: dx spine (b)(6) 2020;dx spine (b)(6) 2020;dx spine (b)(6) 2020;cr spine (b)(6) 2020;cr spine (b)(6) 2020;cr spine (b)(6) 2017; findings / impression: t8 to sacrum/ilium revision posterior spinal instrumentation and decompression is unchanged in appearance and alignment.There is an allograft/cement at t9 body, and of l1 through ileum.Interval fusion l1-l2, l3-l4, l4-l5.Similar t8 pedicle screw fracture, likely right.Interval removal of surgical staples.C3-c7 anterior cervical fusion visualized].Nurse (b)(6) scheduled a neurosurgery follow-up with (b)(6) in 3 months for fu hardware revision.On (b)(6) 2020: (b)(6) ordered scoliosis standing pa <(>&<)> lat for s/p hardware revision.(b)(6) neurosurgery clinic notes- chief complaint: follow-up left-sided spinal hardware revision; history of present illness: patient has very complex spinal surgical history which began with a t8 to ilium fusion by our team in october 2017 which later required hardware revision in (b)(6) 2019 due to rod breakage, and subsequently he had a recurrent right rod breakage for which he underwent another revision surgery (b)(6)2020, and at his postoperative follow-up visit after that a left sided rod breakage was discovered and he therefore underwent left-sided rod revision on (b)(6) 2020.Notably during each of these 2 most recent surgeries the s1 screw was found to be loose on the operated side and so the s1 screw was replaced each time.He returns for routine 6-week follow-up after his most recent left-sided rod revision surgery.He was discharged to acute rehab on postoperative day 5 and spent 10 days there and was then discharged home.He is supposed to start physical therapy as an outpatient but has not yet done so because he wants to see us first to determine whether t here is any additional hardware failure.Unrelated to his spinal hardware, he was scheduled for work-up for huntington's disease on (b)(6) 2020 but only got about half of the work-up done.He still has yet to see the neurology movement disorder clinic but did complete his neuropsych testing.Finally, the patient reports severe back pain around the site of the surgery.He denies any leg pain or leg weakness or arm pain or arm weakness.Assessment: patient presents with 6-week follow-up after undergoing a second of 2 recent hardware revision due to rod breakage of a long segment spinal fusion.Today there is no evidence of hardware failure.We will follow-up again in 3 months with routine postop checkup with scoliosis films.Plan: follow up 3 months with scoliosis films, recommend starting outpatient pt, 30 pound weight lifting restriction otherwise no activity restrictions from neurosurgery perspective, recommend neurology evaluation for possible huntington's disease.Nurse (b)(6) scheduled a neurosurgery follow up with (b)(6) in 3 months for fu hardware revision.On (b)(6) 2021: patient had scoliosis standing pa <(>&<)> lat scheduled by (b)(6) for arthrodesis status, s/p hardware revision.It was compared to dx spine (b)(6) 2020;dx spine (b)(6) 2020;dx spine (b)(6) 2020;cr spine (b)(6) 2020;cr spine (b)(6) 2020;cr spine (b)(6) 2017.Findings / impression: postsurgical changes of t8-sacrum posterior spinal fusion with bilateral iliac screws.Intervertebral disc spacers between l2-l3, l4-l5, and l5-s1.Stable appearance of the allograft/cement of the t9 vertebra.Similar t8 pedicle screw fracture.No new acute hardware complication.Stable mild levocurvature of the thoracolumbar spine.Partially visualized anterior spinal fusion from c3-c7.Dr.Oya¿s neurosurgery progress notes- chief complaint: follow-up left-sided spinal hardware revision; history of present illness: patient has a very complex spinal surgical history which began with a t8 to ilium fusion by our team in (b)(6) 2017 which later required hardware revision in (b)(6)2019 due to rod breakage, and subsequently he had a recurrent right rod breakage for which he underwent another revision surgery (b)(6) 2020, and at his postoperative follow-up visit after that a left sided rod breakage was discovered and he therefore, underwent left-sided rod revision on (b)(6) 2020.Notably during each of these 2 most recent surgeries the s1 screw was found to be loose on the operated side and so the s1 screw was replaced each time.He returns for routine 3 month follow-up after his most recent left-sided rod revision surgery.He was discharged to acute rehab on postoperative day 5 and spent 10 days there and was then discharged home.He has completed his physical therapy which she says helped with overall mobility and function.His back pain is improved since he was last seen.He does continue to endorse a dull, achy pain that can be as bad as 6-7 out of 10 especially at night when laying down but he does say that it is slowly getting better.He also endorses progressive numbness and tingling in all of his fingertips and toes that has responded to medication but continues to cause some difficulty with sleeping.Overall, he feels that he is significantly improved from last time he was seen.Assessment: patient who presents with 6-week follow-up after undergoing a second of 2 recent hardware revision due to rod breakage of a long segment spinal fusion.There is no evidence of hardware failure.We will follow-up again in 3 months with routine postop checkup with scoliosis films.Plan: no activity restrictions from neurosurgery perspective, follow-up neurosurgery on an as-needed basis, further evaluation and management of suspected huntington's disease per neurology.On (b)(6) 2021: (b)(6) scheduled a neurosurgery follow up with (b)(6) in 2 weeks.(b)(6) ordered external ct abdomen/ pelvis and external x-ray l spine.Patient presented with concern for hardware malfunction, bump at back, imaging may be cause for concern.He went to the local ed complaining of new onset back and abdominal pain which he stated was similar to his previous hardware failure symptoms.Local ed obtain a ct abdomen/pelvis and x-ray of the lumbar spine.Local provider says he has no neurological deficits at all.He also states that there are no concerns about any abdominal pathology.He is calling regarding possible screw lucency of the l4 on 1 side.Local provider reviewed the imaging.The rods both appear intact within what he can visualize on the x-rays.It is possible that one of the setscrews, perhaps a right l4, is loose.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10633412
• MDR Text Key: 210390771
• Report Number: 1030489-2020-01375
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K131321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1555200500
• Device Catalogue Number: 1555200500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 64