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

Model Number UNK_NAV_SYS

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

Patient Problems Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 12/07/2022

Event Type  Injury  

Event Description

Croci, d.M., nguyen, s., streitmatter, s.W., sherrod, b.A., hardy, j., cole, k.L., gamblin, a.S., bisson, e.F., mazur, m.D., <(>&<)>amp; dailey, a.T.(2022).O-arm accuracy and radiation exposure in adult deformity surgery.World neurosurgery.Https://doi.Org/10.1016/j.Wneu.2022.12.034 summary: objective: in long thoracolumbar deformity surgery, accurate screw positioning is critical for spinal stability.We assessed pedicle and pelvic screw accuracy and radiation exposure in patients undergoing long thoracolumbar deformity fusion surgery (= 4 levels) involving 3- dimensional fluoroscopy (o-arm/stealth) navigation.Methods: in this retrospective single-center cohort study, all patients aged >18 years who underwent fusion in 2016-2018 were reviewed.O-arm images were assessed for screw accuracy.Effective radiation doses were calculated.The primary outcome was pedicle screw accuracy (heary grade).Secondary outcomes were pelvic fixation screw accuracy, radiation exposure, and screw-related perioperative and postoperative complications or revision surgery within 3 years results: of 1477 pedicle screws placed in 91 patients (mean 16.41 ± 5.6 screws/patient), 1208 pedicle screws (81.8%) could be evaluated by 3-dimensional imaging after placement.Heary grade i placement was achieved in 1150 screws (95.2%), grade ii in 47 (3.9%), grade iii in 10 (0.82%), grade iv in 1 (0.08%), and grade v in 0; grade iii-v were replaced intraoperatively.One of 60 (1.6%) sacroiliac screws placed showed medial cortical breach and was replaced.The average o-arm-related effective dose was 29.54 ± 14.29 msv and effective dose/spin was 8.25 ± 2.65 msv.No postoperative neurological worsening, vascular injuries, or revision surgeries for screw misplacement were recorded.Conclusions: with effective radiation doses similar to those in interventional neuroendovascular procedures, the use of o-arm in multilevel complex deformity surgery resulted in high screw accuracy, no need for surgical revision because of screw malposition, less additional imaging, and no radiation exposure for the surgical team reported event: 1.Ninety-one patients underwent long thoracolumbar deformity surgery.Overall revision surgery occurred within the 3-year follow-up period in 28 patients (30.7%).2.Ninety-one patients underwent long thoracolumbar deformity surgery.Revision surgery for wound complications and infection occurred in 6 patients (6.5%).3.Ninety-one patients underwent long thoracolumbar deformity surgery.Revision surgery for proximal junctional kyphosis (pjk) occurred in 13 patients (14.2%).See attached literature article.

Manufacturer Narrative

Patient information was not included in the journal entry.This value reflects the mean age of the patients who underwent the long thoracolumbar deformity procedure as specific patients could not be identified.This value reflects the majority gender of the patients who underwent the long thoracolumbar deformity procedure as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the accepted date.The article citation is included.The system product number and serial number were not provided in the journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as the event was reported as a literature article.Device manufacturing date is 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.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.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16297053
• MDR Text Key: 308782260
• Report Number: 1723170-2023-00157
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2023

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?: No
• 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: 01/31/2023
• Initial Date FDA Received: 02/03/2023
• 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: 60 YR
• Patient Sex: Female