Sawarkar, d.P., singh, p.K., agrawal, d., satyarthee, g.D., gupta, d.K., tandon, v., gurjar, h.K., borkar, s., jagdevan, a., mishra, s., kedia, s., sharma, r., doddamani, r., verma, s., meena, r., kumar, r., chandra, r.S., kale, s.S.O-arm assisted anterior odontoid screw fixation in type ii and rostral type iii odontoid fractures: single center surgical series of 50 patients.Neurological society of india.2022.70 (s135-43).Doi: 10.4103/0028-3886.360924.Abstract: background: accuracy of screw placement is one of the important factors necessary for adequate union in odontoid fractures with malposition rates as high as 27.2% with standard techniques.Objective: to evaluate efficacy of intraoperative o-arm assistance in improving accuracy of anterior odontoid screw placement and cl inco-radiological outcome in type ii and iii odontoid fractures.Material and methods: in this retrospective study, surgery consisted of anterior odontoid screw fixation under intraoperative o-arm assistance over 5 years.Demographical, clinical, radiological, operative details and postoperative events were retrieved from hospital database and evaluated for fusion and surgical outcome.Results: 50 patients (mean age 34.6 years, sd 14.10, range: 7¿70 years; 44 males and 6 females) with type ii and type iii odontoid fracture underwent o-arm assisted anterior screw placement.The mean interval between injury and surgery was 12 days (range 1¿65 days).Mean operating time was 132.2 min ± sd 33.56 with average blood loss of 93 ml.±sd 61.46.With our technique, accurate screw placement was achieved in 100% patients.At the mean follow-up of 26.4 month (sd13.75), overall acceptable fusion rate was 97.8% with non-union in 2.2% patients.Morbidity occurred in two patients; one patient developed fixation failure while other patient had nonunion which was managed with posterior c1-c2 arthrodesis.We had surgical mortality in one patient due to sah.So overall our procedure was successful in 94% patients and among patients whose follow-up was available, acceptable fusion rates of 97.8% were achieved.Conclusion: we conclude that use of intraoperative three-dimensional imaging using o-arm for anterior odontoid screw fixation improves accuracy and leads to improved radiological and clinical outcomes.It further enables us to extend the indications of odontoid screw fixation to selected complex type ii and rostral type iii odontoid fractures.Reported events: one patient had a nonunion which was managed with posterior c1-c2 arthrodesis.One patient with high type, type iii fracture had failure of fixation at 3rd postoperative day due to the screw cut through even after successful screw placement.Presence of small anterior fractured chip fragment resulting in poor bone purchase could be the reason for screw cut through.One patient had a failure of fixation requiring posterior salvage surgery one patient had a k wire breakage during drilling but successfully managed by odontoid screw placement without any complication 14 patients who had neurological deficits, showed improvement in their neurological deficits.One patient developed a fixation failure.
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Age or date of birth: patient age is the mean value of patients in the study.Sex: patient gender is the majority value of patient in the study.Weight: patient weight not available from the site.Date of event: event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.Pma/510k: 510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.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.
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H2) literature article is in the attachment area.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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