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 Hemorrhage/Bleeding (1888); Respiratory Tract Infection (2420); Post Operative Wound Infection (2446); Thrombosis/Thrombus (4440)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

A2.Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.A3.Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.B3.Please note that this date is based off the date of publication of the article as the actual event date was not provided.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

Mai shiber, gil kimchi, nachshon knoller, and ran harel.The evolution of minimally invasive spine tumor resection and stabilization: from k-wires to navigated one-step screws.Journal of clinical medicine.2023, 12, 536.Doi: 10.3390/jcm12020536.Abstract: minimization of the surgical approaches to spinal extradural metastases resection and stabilization was advocated by the 2012 oncological guidelines for spinal metastases management.Minimally invasive approaches to spine oncology surgery (miss) are continually advancing.This paper will describe the evolution of minimally invasive surgical techniques for the resection of metastatic spinal lesions and stabilization in a single institute.A retrospective analysis of patients who underwent minimally invasive extradural spinal metastases resection during the years 2013¿2019 by a single surgeon was performed.Medical records, imaging studies, operative reports, rates of screw misplacement, operative time and estimated blood loss were reviewed.Detailed description of the surgical technique is provided.Of 138 patients operated for extradural spinal tumors during the study years, 19 patients were treated in a minimally invasive approach and met the inclusion criteria for this study.The mortality rate was significantly improved over the years with accordance of improve selection criteria to better prognosis patients.The surgical technique has evolved over the study years from fluoroscopy to intraoperative 3d imaging and navigation guidance and from k-wire screw insertion technique to one-step screws.Minimally invasive spinal tumor surgery is an evolving technique.The adoption of assistive devices such as intraoperative 3d imaging and one-step screw insertion systems was safe and efficient.Oncologic patients may particularly benefit from the minimization of surgical decompression and fusion in light of the frailty of this population and the mitigated postoperative outcomes associated with mis oncological procedures.Reported events: 1 patient experienced excessive bleeding intraoperatively.1 patient experienced a respiratory infection postoperatively.1 patient experienced a deep wound infection postoperatively.1 patient experienced deep vein thrombosis postoperatively.

• 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: 17611246
• MDR Text Key: 321826391
• Report Number: 3004785967-2023-00516
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2023

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_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: 08/03/2023
• Initial Date FDA Received: 08/24/2023
• 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): Other
• Patient Age: 60 YR
• Patient Sex: Female