MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL; SEE H10)
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Model Number S7 |
Device Problem
Imprecision (1307)
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Patient Problems
Perforation (2001); Iatrogenic Source (2498)
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Event Date 12/18/2016 |
Event Type
Injury
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Manufacturer Narrative
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Patient information was unavailable from the author.According to the article, 27 patients, the average age was 16.1 years old.Therefore, 16 years old used for patient age.Event date is approximated.Date is based on the article accepted date which is (b)(6) 2016.Citation: wei z, tomoyuki t, yonggang w, yoshihisa s, masato t, toshifumi o (2016) accuracy of pedicle screw insertion in posterior scoliosis surgery: a comparison between intraoperative navigation and preoperative navigation techniques.Eur spine j (2017) 26:1756-1764.Doi 10.1007/s00586-016-4930-5.No procode, common device name and/or 510(k) provided as this device is not released for distribution in the united states.Multiple attempts have been made to obtain additional information.Upon follow up, the author and physician reported that there was no issues caused or contributed by medtronic devices/products.Per the journal article, the most common location of misplacement was around the apex vertebra (t7¿9) of the curve.Moreover, some misplaced pedicle screws were in the proximal thoracic spine at the apex of the thoracic curve (t3¿t4) whether it was a structural curve or nonstructural curve.This is because apex pedicles of both structural and nonstructural curves are smaller and more rotated.The direction of misplacement was commonly a medial breach on the convex side or a lateral breach on the concave side.No request for service have been received from the customer regarding these events.No parts have been replaced or returned to the manufacturer for evaluation.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's intraoperative imaging system and navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
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Event Description
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The journal article was forwarded by a medtronic representative.Use of imaging system and navigation system for pedicle screw insertion was reported.The study started on january 2009 and ended on june 2015.27 patients who underwent intraoperative navigation-based insertion of 492 pedicle screws.The mean ages at the time of operation were 16.1 years (range 12¿24 years).The number of pedicle screws per vertebra in the apical region (apex ± 2 vertebrae), and the coronal cobb angle of the main thoracic curve using pre- and postoperative full-length standing radiographs and ct per patient.In the intraoperative navigation group, article reported 474 (96.3%) of the 492 pedicle screw placements as safe (grades 0; no perforation, 1; perforations less than 2 mm), 16 (3.3%) as grade 2 (perforation more than 2mm but less than 4 mm), and 2 (0.4%) as grade 3 (perforation more than 4 mm).There was no statistically significant difference between preoperative and intraoperative group with respect to the accuracy rate of the pedicle screw placement (table 2).The most common location of misplacement was around the apex vertebra (t7¿9) of the curve.Moreover, some misplaced pedicle screws were in the proximal thoracic spine at the apex of the thoracic curve (t3¿t4) whether it was a structural curve or nonstructural curve.This is because apex pedicles of both structural and nonstructural curves are smaller and more rotated.The direction of misplacement was commonly a medial breach on the convex side or a lateral breach on the concave side.When considering technical error in the current study, the incidence of perforation was 1.6% (8/492) of the intraoperative group.When comparing our two intraoperative navigation units (o-arm vs arcadis), there was no statistical difference.Moreover, the pedicle screw accuracy rate on the apical region was higher in the intraoperative navigation group (94.8%, 199/210), and the incidence of medial perforation was particularly high in the preoperative ct-based navigation group.
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