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Mohammed banat, johannes wach, abdallah salemdawod, gregor bara, jasmin scorzin, hartmut vatter : indications for early revision surgery for material failure in spinal instrumentation: experience at a level 1 center for spinal surgery a single-center ¿ study summary: posterior instrumentation is an established treatment for a range of spinal disorders.Material failure is not uncommon, and the indications for a revision are very heterogeneous.This study aimed to evaluate the indications and timing for early revision spinal surgery due to material failure.Our data show that the peak time for early revision of material failure after posterior instrumentation was within the first 4months of primary surgery.The abnormalities (e.G., radiolucent zones) surrounding the screws without fusion, including persistence of pain, were predictors for revision surgery.This retrospective, single-center cohort study included all patients with complete data who underwent posterior spinal instrumentation with fusion between january 2017 and july 2019.Follow up computed tomography (ct) scans were conducted after 3 and 12months and clinical postoperative evaluations at 3, 12, and 18 months.In case of clinical deterioration, patients are encouraged to report immediately.The primary surgery was undertaken for instability owing to fracture, tumor, infection, or degenerative deformity.All patients were over 18 years of age.All patients received posterior stabilization the primary operation using the same standardized workflow (including median posterior approach and navigation system) and the same instruments by three neurosurgeons with long years¿ experience in spine surgery.Our standard surgical procedure consists of the following steps: median dorsal posterior approach, open transpedicular screw implantation we do not use percutaneous system-, spinal canal decompression via laminectomy, facetectomy, followed by peek cage implantation, and bone implantation for fusion.In cases of spinal tumor (for example, bone metastasis), we implanted screws in the same technique with spinal canal and nerve root decompression in combination with posterior bone fusion, in these cases we have not used cages, but master-graft granules (firm medtronic) for the posterior fusion.We used peek cages for all posterior instrumentation sub thoracic spine th 4 in posterior lateral interbody fusion technique.For the thoracic spine, we used additionally costotransversectomy to implant the cages.Revision surgery was necessary due to: (1) secondary instability with material breakdown and loss of spinal stability; (2) detection of radiolucent zones around the screws during the ct check; (3) pseudarthrosis in combination with increased back pain.Those factors are our institutional indications for revision surgery.During the revision surgery, old material was removed, loosened screws were replaced with thicker screws, and the instrumentation was extended in the appropriate direction.Undertaken, sonication of the removed screws was before revision ct and mri scans were conducted.A total of 153 patients were recruited.The majority of patients (52.3%) underwent a lumbar spine surgery; the most common pathology was a degenerative disease (34%).The indication for revision was based on the treatment-refractory pain symptoms and on the image proof of morphological instability (radiolucent zones, break down of material, and non-fusion).Our data show that patients with radiolucent zones had increased pain 3months after surgery (there were 30 patients with radiolucent zones and 123 patients without).The relationship between pain and radiolucent zones was no more significant 12months after surgery (48 patients with radiolucent zones and 105 patients without) the relationship between pain and radiolucent zones was no more significant 12months after surgery (48 patients with radiolucent zones and 105 patients without) and additionally break down of material; two of them (patient nr.9 and 10) had radiolucent zones; based on these facts, the revision was carried out.Reported events: 1.Overall 13 patients has received the revision surgery due to material break down of screw, radiolucent zones and non-fusion.2.Overall 13 patients has received the revision surgery due to material break down of peek cage, radiolucent zones and non-fusion.
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Mohammed banat, johannes wach, abdallah salemdawod, gregor bara, jasmin scorzin, hartmut vatter : indications for early revision surgery for material failure in spinal instrumentation: experience at a level 1 center for spinal surgery a single-center ¿ study: http ://dx.Doi.Org/10.1097/md.0000000000028410.A3: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B3: date that the article was accepted for as the event dates were not provided in the published literature.D4: product identifiers are unknown.H6: 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.G3: 510(k)# is unknown.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.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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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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