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 Dysphagia/ Odynophagia (1815); Hematoma (1884); Spinal Column Injury (2081); Respiratory Failure (2484); Unspecified Nervous System Problem (4426)

Event Date 02/21/2022

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 accepted 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

Nie, j.Z., weber, m.W., revelt, n.J., nordmann, n.J., watson, v.L., nie, j.W., menezes, s.A., delfino, k., cozzens, j.W., espinosa, j.A., amin, d., acakpo-satchivi, l.Comparison of using intraoperative computed tomographyebased 3-dimensional navigation and fluoroscopy in anterior cervical diskectomy and fusion for cervical spondylosis.World neurosurg.2022.161 (e740-e747).Https://doi.Org /10.1016/j.Wneu.2022.02.089 - objective: anterior cervical diskectomy and fusion (acdf) is a highly successful procedure to treat spinal cord or nerve root compression; however, complications can still occur.With advancements in imaging, 3-dimensional (3d) reconstruction allows real-time instrument tracking in a surgical field relative to the patient¿s anatomy.Here, we compare plate positioning and short-term outcomes when using 3d navigation to fluoroscopy in acdf for degenerative spine disease.- methods: all acdfs for cervical spondylosis performed by 6 surgeons at a single center between 2010 and 2018 were included.Acdfs were divided into those performed using 3d navigation or fluoroscopy.Records were assessed for patient demographics, american society of anesthesiology score, number of operated interspaces, operative time, length of stay, perioperative complications, and 90-day readmissions.Postoperative images were reviewed for lateral and angular plate deviations.- results: a total of 193 acdfs performed with 3d navigation and 728 performed with fluoroscopy were included.After controlling for demographics and surgical characteristics, using 3d navigation was associated with less lateral plate deviation (p [ 0.048) and longer operative times per interspace (p <(><<)> 0.001) but was not associated with angular plate deviation (p [ 0.724), length of stay (p [ 0.393), perioperative complications (p [ 0.844), and 90-day readmissions (p [ 0.539).- conclusions: using 3d navigation in acdf for degenerative disease is associated with slightly more midline plate positioning and comparable short-term outcomes as using fluoroscopy and can be a suitable alternative.Advantages of using this technology, such as improved visualization of anatomy, should be weighed against disadvantages, such as increased operative time, on a per-patient basis.Reported events: 23 patients with dysphagia 1 patient with neurologic injury 3 patients with durotomy 5 patients with hematomas 1 patient with hardware failures 3 patients with respiratory failures 2 patients with other issues 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: 16163303
• MDR Text Key: 309033838
• Report Number: 3004785967-2023-00040
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2023

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: 01/06/2023
• Initial Date FDA Received: 01/13/2023
• 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: 60 YR
• Patient Sex: Female