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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Emphysema (1832); Post Operative Wound Infection (2446); Thrombosis/Thrombus (4440)

Event Date 03/02/2023

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

Crawford, a.M., striano, b.M., lightsey, h.M., gong, j., simpson, a.K., schoenfeld, a.J.Intraoperative ct for lumbar fusion is not associated with improved short- or long-term complication profiles.The spine journal.2023.000 (1-8).Doi: https://doi.Org/10.10 16/j.Spinee.2023.02.016 abstract background context the use of intraoperative ct has continued to grow in recent years, as various techniques leverage the promise of improved instrumentation accuracy and the hope for decreased complications.Nonetheless, the literature regarding the short- and long-term complications associated with such techniques remains scant and/or confounded by indication and selection bias.Purpose to use causal inference techniques to determine whether intraoperative ct use is associated with an improved complication profile as compared to conventional radiography for single-level lumbar fusions, an increasingly commonplace application for this technology.Study design/setting inverse probability weighted retrospective cohort study carried out within a large integrated health care network.Patient sample adult patients who underwent surgical treatment of spondylolisthesis via lumbar fusion from january 2016 to december 2021.Outcome measures our primary outcome was the incidence rate of revision surgery.Our secondary outcome was the incidence of composite 90-day complications (deep and superficial surgical site infection, venous thromboembolic events, and unplanned readmissions).Methods demographics, intraoperative information, and postoperative complications were abstracted from electronic health records.A propensi ty score was developed utilizing a parsimonious model to account for covariate interaction with our primary predictor, intraoperative imaging technique.This propensity score was utilized in the creation of inverse probability weights to adjust for indication and selection bias.The rate of revisions within 3 years as well as the rate of revisions at any time-point were compared between cohorts using cox regression analysis.The incidence of composite 90-day complications were compared using negative binomial regression.Results our patient population consisted of 583 patients, with 132 who underwent intraoperative ct and 451 who underwent conventional radiographic techniques.There were no significant differences between cohorts following inverse probability weighting.No significant differences were detected in 3-year revision rates (hr, 0.74 [95% ci 0.29, 1.92]; p=.5), overall revision rates (hr, 0.54 [95% ci 0.20, 1.46]; p=.2), or 90-day complications (rc -0.24 [95% ci ¿1.35, 0.87]; p=.7).Conclusions intraoperative ct use was not associated with an improved complication profile in either the short- or long-term for patients undergoing single-level instrumented fusion.This observed clinical equipoise should be weighed against resource and radiation-related costs when considering intraoperative ct for low complexity fusions.Reportable events: ninety-day adverse events were recorded in 8% of the entire cohort 14 patients experiences superficial surgical site infections 5 patients experienced deep surgical site infections 4 patients experienced deep vein thrombosis or pulmonary embolism 25 patients were readmitted to the hospital the health care professional stated that they maintain that of the adverse events that were mentioned within the article, none of them relate directly to the medtronic imaging system itself.See attached literature article.

• 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: 16953232
• MDR Text Key: 316282514
• Report Number: 3004785967-2023-00306
• Device Sequence Number: 1
• Product Code: OXO
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/27/2023
• Initial Date FDA Received: 05/18/2023
• 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: 62 YR
• Patient Sex: Female