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It was reported via patient call that the patient had undergone 5-level fusion.From an unknown date, post-op, she has been experiencing continued pain.She also stated that her surgeon said that her x-rays look good.Allegedly, the patient has been diagnosed with arachnoiditis and has difficulty with her legs.The patient also complained of complex region pain syndrome, flat back syndrome, major nerve damage.Reportedly, there was also extra bone growth due to which she could not receive any shots in her back for pain.The surgeon has recommended her for a revision surgery.Allegedly, while conducting tests, technician said that it was very difficult to get the needle in due to high amount of bone growth.
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The patient alleged suffered from hetero topic ossification, flat back syndrome (loss of curvature in back surgery), chronic reg.Pain syndrome, cauda equina synd.(complete loss of bladder, severe weakness in legs), arachnoiditis(electric shocking of lower back an legs), paralysis (on left side of vaginal area and thigh).01 aug 2014: the patient presented with the following pre-operative diagnosis: 1) l3-4 and l4-5 spondylolisthesis.2) bilateral lumbar radiculopathy and severe foraminal stenosis.3) diffuse idiopathic skeletal ¿hyperosmosis¿ with posterior calcification of ligamentum flavum diffusely through the lumbar spine.4) severe central and lateral recess stenosis.5) morbid obesity, body mass index of 50.She underwent the following procedures: 1) segmental instrumentation, l2 to iliac usingscrew and rod systems including iliac screws.2) l2 to sacrum posterior lateral arthrodesis with use of autograft, 30ml of grafton, bmp medium infuse, 15ml of crushed cancellous.3) l3 to sacrum laminectomies.4) right l3-4 transforaminal interbody fusion with placement of interbody cage.5) left 4-5 transforaminal interbody fusion with placement of interbody cage.6) bilateral osteotomies at l3-4, l4-5, l5-s1 and correction of degenerative scoliotic deformity.7) use of operative microscope.As per the operative notes, ¿the posterior lateral t-piece were prepared for arthrodesis with a midas drill and decorticated.The remaining lamina at the sacrum as well as l2 and l3 were decorticated as well.Posterior lateral fusion mass was then placed using 30ml of grafton, 15ml of crushed cancellous chips, a medium bmp infuse as well as the patient¿s autograft.Autograft was harvested from the lamina as well as the spinous processes during the operation.1/2g of ¿vomc¿ powder was placed in the subfascial space and then placed in the superfascial space.Two subfascial dezins were placed into the wound.The wound was closed in anatomical fashion.¿ no intra-operative complications were reported.As per op-notes, "incision then made with a 10 blade knife through the skin and subcuticular.Continued dissection with bovie cautery down to the lumbar fascial.A periosteal dissection was then undertaken and exposure of the facets joints from l2 down to sacrum was completed using the bovie cautery and cobb instrument.I continued the dissection post laterally, exposing the t-piece at l2, l3, l4, l5 and the sacrum.Wiltse gelpi were used for retraction.Once this exposure was completed, exposure was tuned toward the placement of pedicle screws.Using anatomical landmarks and fluoroscopy, then the pedicle screws wereaccessed using lenke probe, palpated with the feeler to confirm correct location and then the pedicle was tapped and then screw was placed.The following instrumentation was placed using the same method in each level.At l2, 6.5*45*2; at l3, 6.5*45*2; at l4, 7.5*50*2; at s1, 7.5*40*2.Once this was completed, an ap and lateral x ray showed adequate placement of pedicle screw instrumentation from l2 to sacrum.The t-piece were decorated sing the midas drill in preparation for posterior lateral arthodesis later in the case.The operative microscope was then brought into the field per microsurgical technique in dissection.Attention then turned toward the decompression portion of the operation beginning at l3-4 on the right side, which was the level of concavity of the patient¿s coronal scoliotic deformity.A complete laminectomy was initially performed down to the ligamentum flavum was diffusely calcified and adherent to dura.A 11 blade used to perform the annulotomy.Discectomy then performed with the same same technique as above.A 9mm trial inserted into the 4-5 disk space.Endplates prepared for arthrodesis with curette instrument.A 9 mm trial was then attached.The anterior interbody space was filled with autograft and allograft, as well as the implant and then inserted into the 4-5 disk space under the direction of fluoroscopy without difficulty.The disk space was accessed but it was too collapsed in order for an implant or cage to be inserted into it, therefore a posterior lateral arthrodesis sufficed at this level.At this point in time, the wound was irrigated completely.There was adequate decompression now from l3 to sacrum with placement of grafts at two levels, as well asbilateral osteotomies at l3-4, l4-5, l5-s1.Attention then turned toward placement of iliac screws fluro was placed, so that iliac pedicle was well visualized.Drill used to create a pilot hole, lenke probe inserted down the pedicle of the iliac.A 7.5*70 mm iliac screw was placed on the left and right using technique.Two 35 mm connectors were then attached to iliac screws and then secured with set screw.The rods contoured for a fit, placed into set screws, tightened.Compression was completed at the convexity of the coronal curve for a mild correction of the patient¿s scoliotic deformity at l3-4 and l4-5.Once the rod was then placed, set screws were inserted, tightened using the torqueing mechanism, the caps were broken off a l2,3 ,4,5 and s1.The iliac screw cap was broken off as well.This was done bilaterally.Ap and lateral x-ray showed adequate placement of pedicle screw as well as the connector with a good reduction of the coronal deformity".
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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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