MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7; INSTRUMENT, STEREOTAXIC

Model Number 9733858

Device Problem Imprecision (1307)

Patient Problems Hemorrhage/Bleeding (1888); Swelling (2091); Post Operative Wound Infection (2446); No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal article.This value is the mean age of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date the article was accepted as the event dates were not provided in the published literature.Article citation is included.System serial number not provided in journal article.Udi not available for this system.No evaluation was performed as this event was reported in literature.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: dinesh shree kumar, nishanth ampar, loo wee lim, accuracy and reliability of spinal navigation: an analysis of over 1000 pedicle scr ews, journal of orthopaedics, volume 18, 2020, pages 197-203, issn 0972-978x, https://doi.Org/10.1016/j.Jor.2019.10.002.Summary: purpose: to estimate the rate of pedicle screw malpositioning associated with placing pedicle screws using intraoperative computed tomography (ct)-guided spinal navigation.Methods: we analysed the records of 219 patients who underwent pedicle screw fixation using o-arm-based navigation.Screw placement accuracy was evaluated on intraoperative ct scans acquired after pedicle screw insertion.Breaches were graded according to the gertzbein classification (grade 0¿iii).Results: of 1152 pedicle screws included, 47 had pedicle violations noted on intraoperative ct.Pedicle screw violation was noted for 17 of 241 screws placed in the cervical spine (overall breach rate, 7.05%; 3.73% and 3.3% with grade i and ii, respectively), for 11 of 300 screws placed in the thoracic spine (overall breach rate, 3.67%; 2%, 1%, and 0.67% with grade i, ii, and iii, respectively), and for 22 of 611 screws placed in the lumbar spine (overall breach rate, 3.6%; 2.29% and 0.82% with grade i and ii, respectively).The rate of accuracy of pedicle screw fixation was 93%, 96.33%, and 96.4% for the cervical, thoracic, and lumbar spine, respectively.Conclusions: using o-arm-based intra-operative three-dimensional scans for navigation can improve the reliability, accuracy, and safety of pedicle screw placement, reducing the risk for reoperation and hospitalization due to implant-related complications.Further improvement may be achieved by adequate consideration of potential sources of errors.Reported events: of the 241 screws placed in the cervical spine, 17 had pedicle violations (9 screws grade i breach, 8 screws grade ii breach).Of the 300 screws placed in the thoracic spine, 11 had pedicle violations (6 screws grade i breach, 3 screws grade ii breach, 2 screws grade iii breach).Of the 611 screws placed in the lumbar spine, 22 had pedicle violations (14 screws grade i breach, 5 screws grade ii, perforation of the anterior cortex occurred for 2 screws, perforation of the anterolateral cortex occurred for 1 screw).All screws with grade ii or grade iii breach were revised after analyzing the intra-operative images within the same operation thereby avoiding the need for reoperation due to screw malposition.It was reported that none of the malpositioned screws resulted in complications.One patient developed large swelling around the site of incision made for docking the reference array over the t6 spinous process.It reported that on-re-exploration, it was noted that there was an active bleeder in the paraspinal muscle tissue; the bleeder was coagulated and haemostasis was achieved; the patient had an otherwise uneventful recovery.Two patients who underwent minimally invasive instrumentation of the lumbar spine developed superficial wound infections and delayed wound healing at the site of the incision made for docking the reference array; both patients were managed successfully with regular wound dressing.

Manufacturer Narrative

H2) additional information: see b5.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.

Event Description

Medtronic received information that the reported adverse events were not related to medtronic products and were related to surgical techniques.

• Brand Name: STEALTHSTATION® S7
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9720976
• MDR Text Key: 190064847
• Report Number: 1723170-2020-00548
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733858
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR