MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M

Model Number UNK_OARM_SYS

Device Problem Imprecision (1307)

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Post Operative Wound Infection (2446); Cardiovascular Insufficiency (4445); Unspecified Tissue Injury (4559)

Event Date 06/30/2022

Event Type  Injury  

Event Description

Sargut.T.A., hecht, n., xu, r., bohner, g., czabanka, m., stein, j., richter, m., bayerl, s., woitzik, j., vajkoczy, p.Intraoperative imaging and navigated spinopelvic instrumentation: s2-alar-iliac screws combined with tricortical s1 pedicle screw fixation.European spine journal.2022.31(2587¿2596) https://doi.Org/10.1007/s00586-022-07268-x.Abstract purpose: the present study aimed to assess the feasibility, safety and accuracy of navigated spinopelvic fxation with focus on s2-alar-iliac screws (s2ais) and tricortical s1 pedicle screw implantation with the use of high-resolution three-dimensional intraoperative imaging and real-time spinal navigation.Methods: patients undergoing navigated intraoperative ct-based spinopelvic stabilization between january 2016 and september 2019 were included.Pelvic fixation was achieved by implantation of s2ais or iliac screws (is).S1 screws were implanted with the goal of achieving tricortical purchase.In all cases, instrumentation was performed with real-time spinal navigation and intraoperative screw positioning was assessed using intraoperative computed tomography (ict), cone-beam ct (cbct) and robotic cone-beam ct (rcbct).Screw accuracy was evaluated based on radiographic criteria.To identify predictors of complications, univariate analysis was performed.Results: overall, 52 patients (85%) received s2ais and nine patients (15%) received is instrumentation.Intraoperative imaging and spinal navigation were performed with ict in 34 patients, cbct in 21 patients and rcbct in six patients.A total number of 10/128 (7.8%) iliac screws underwent successful intraoperative correction due to misalignment.Tricortical purchase was successfully accomplished in 58/110 (53%) of the s1 screws with a clear learning curve in the course of time.S2ais implantation was associated with significantly fewer surgical side infection-associated surgeries.Conclusions: real-time navigation facilitated spinopelvic instrumentation with increasing accuracy of s2ais and tricortical s1 screws.Intraoperative imaging by ict, cbct or rcbct permitted screw assessment with the chance of direct navigated revision of misplaced iliac screws to avoid secondary screw revision surgery.Reported events: 2 patients had a hematoma 1 patient had an intraoperative major vessel injury requiring endovascular intervention 1 patient had a cerebrospinal fluid (csf) fistula 9 patients had a surgical site infection 12 patients had reoperation during their hospitalization 10 patients had intraoperative correction of the iliac screw due to misalignment 1 patient required intraoperative correction of a screw due to a lateral pedicle breach >4 millimeters.

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.

• Brand Name: O-ARM IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15844360
• MDR Text Key: 304113543
• Report Number: 3004785967-2022-00776
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/22/2022

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_OARM_SYS
• Device Catalogue Number: UNK_OARM_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 11/22/2022
• 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: 69 YR
• Patient Sex: Female