A total of 97 patients (45 males and 52 females) were treated with a viper2 or expedium system instruments.Exact date of event is unknown; (b)(6) 2018 is the date the literature article was published.This report is for an unknown mono/polyaxial screw/unknown lot.Part and lot number are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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This report is being filed after the review of the following journal article: scarone, p.Et al.(2018), use of the airo mobile intraoperative ct system versus the o-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients, journal of neurosurgical spine, vol.29, pages 397-406 (switzerland).The primary objective of this study was to compare the in vivo accuracy of these 2 navigation-enabling technologies during pedicular screw positioning at the thoracic and lumbar levels during percutaneous and open surgeries.Determining the rate of intraoperative screw repositioning, postoperative clinical results, surgical time, and radiation exposure were secondary objectives.Between january 2013 and november 2015, a total of 97 patients (45 males and 52 females) were treated with a viper2 or expedium system instruments.The following complications were reported as follows: (in this study, heary grade 1¿3 screws were considered correctly placed, and heary grade 4 and 5 screws were considered misplaced.) 6 screws were heary grade 4.7 screws were repositioned intraoperatively.A (b)(6) year old female patient experienced a partial motor deficit (m2) in her right foot after medial repositioning of an l5 pedicle screw in open surgery that needed a new intervention on postoperative day 1.The screw was classified as heary grade 4 on the final intraoperative ct image that was acquired before repositioning.The new screw position was not verified by an intraoperative scan.This report is for an unknown mono/polyaxial screws.This is report 9 of 10 for (b)(4).Additional devices are captured on related complaints (b)(4).A copy of the literature article is being submitted with this medwatch.
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