MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; INSTRUMENT, STEREOTAXIC

Model Number UNK_NAV_SYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

Patient weight not available from the site.Device lot number, or serial number, unavailable.510(k) not provided as the serial number is unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: jung-woo hur, md, jin-sung kim, md, phd, kyeong-sik ryu, md, phd, and myeong-hoon shin, md, phd.Accuracy and safety in screw placement in the high cervical spine: retrospective analysis of o-arm-based navigation-assisted c1 lateral mass and c2 pedicle screws.Clin spine surg 2019;32:e193-e199) summary: objective: the purpose of present study was to evaluate accuracy, efficiency, and safety of intraoperative o-arm¿based navigation system for the placement of c1 lateral mass screw (c1lms) and c2 pedicle screws (c2pss) in high cervical spine operations.Summary of background data: high screw misplacement rates, various pedicle morphometry and vertebral body size variations have led to a search of image-guided systems to improve the surgical accuracy of screw insertion in high cervical spine.The use of o-arm has been proposed for more accurate and efficient spinal instrumentation.Materials and methods: between june 2009 and august 2016, a total of 48 patients with atlantoaxial instability were surgically treated using the image-guidance system.To reconstruct atlantoaxial instability, we have been using harm¿s technique of c1lms and c2ps fixations.A frameless, stereotactic o-arm¿based image-guidance system was used for correct screw placement.Postoperative computed tomographic scan with multiplanar reconstructions were used to determine the accuracy of the screw placement.Results: a total of 182 screws, including 90 c1lms and 92 c2pss were inserted using image-guidance system.In total, 4.4% (4/90) of c1lms and 7.6% (10/92) of c2ps had cortex violation over 2mm and considered as ¿significant.¿ among the significant cortex violations, ¿unexpected breech¿ was 3.3% of all the screws inserted.Two (2.1%) screws inserted had perforated the vertebral artery canal and iatrogenic vertebral artery stenosis was proved with postoperative computed tomography angiography.When divided into time periods, 60% of significant breech occurred during the beginning stage, 40% during adaptation stage and none during expert stage.Conclusions: in this study, the authors demonstrated that use of image-guidance system seems to be beneficial for high cervical instrumentation which requires much experience and steep learning curves.However, incidence of cortex violation does not disappear completely due to the close proximity to spinal canal and surrounding vessels.Reported events: two screws inserted had perforated the vertebral artery canal and iatrogenic vertebral artery stenosis was proved.No neurological complications were observed.One patient presented immediate neurological complications with a c2 fracture due to severe osteoporosis.In 10 procedures, patient not specified, perioperative screw revisions were performed due to wall perforation.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8699800
• MDR Text Key: 148043510
• Report Number: 1723170-2019-03329
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR