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

Model Number UNK_NAV_SYS

Device Problem Imprecision (1307)

Patient Problems Unspecified Infection (1930); Unspecified Tissue Injury (4559)

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, 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.

Event Description

Li, c., li, h., su, j., wang, z., li, d., tian, y., yuan, s., wang, l., liu, x.Comparison of the accuracy of pedicle screw placement using a fluoroscopy-assisted free-hand technique with robotic-assisted navigation using an o-arm or 3d c-arm in scoliosis surgery.Global spine journal.2022.0 (1¿10) https://doi.Org/10.1177/21925682221143076 objectives: to report and compare the application of robotic-assisted navigation with an o-arm or three-dimensional (3d) c-arm-assisted pedicle screw insertion in scoliosis surgery, and compare with free-hand technique.Methods: one hundred and forty-four scoliosis patients were included in this study.Ninety-two patients underwent robotic assisted pedicle screw insertion (group a), and 52 patients underwent freehand fluoroscopy-guided pedicle screw insertion (group b).Group a was further divided into subgroup ai (n = 48; robotic-assisted navigation with an o-arm) and subgroup aii (n = 44; robotic-assisted navigation with a 3d c-arm).The evaluated clinical outcomes were operation time, blood loss, radiation exposure, postoperative hospital stay, and postoperative complications.The clinical outcomes, coronal and sagittal scoliosis parameters and the accuracy of the pedicle screw placement were assessed.Results: there were no significant differences in blood loss and postoperative hospital stay between groups a and b (p =.406, p =.138, respectively).Radiation exposure for patients in group a (subgroups ai or aii) was higher than that in group b (p <(><<)>.005), and subgroup ai had higher patient radiation exposure compared with subgroup aii (p <(><<)>.005).The operation time in subgroup aii was significantly longer than that in subgroup ai and group b (p =.016, p =.032, respectively).The proportion of clinically acceptable screws was higher in group a (subgroups ai or aii) compared with group b (p <(><<)>.005).Conclusions: robotic-assisted navigation with an o-arm or 3d c-arm effectively increased the accuracy and safety in scoliosis surgery.Compared with robotic-assisted navigation with a 3d c-arm, robotic-assisted navigation with an o-arm was more efficient intraoper actively.Reported events: misplacement of screws was 3.9% in subgroup a1 misplacement rate on the concavity was 5.2% in subgroup a1 total 308 misplacement rate on the convexity was 2.6% in subgroup a1 total 312 subgroup ai, the postoperative infection was occurred in 1 patient see attached literature article.

• 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: 16267223
• MDR Text Key: 309275146
• Report Number: 1723170-2023-00123
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 01/25/2023
• 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 Age: 30 YR
• Patient Sex: Female