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 Unspecified Infection (1930); Unspecified Nervous System Problem (4426)

Event Date 06/08/2020

Event Type  malfunction  

Event Description

(b)(6).B.C.Use of 3d navigation versus traditional fluoroscopy for posterior pelvic ring fixation.Orthopedics.2021.44 (4) 229-234.Doi: (b)(4).Abstract: unstable pelvic ring disruption is most commonly treated with closed reduction and percutaneous screw fixation.Traditional methods involve screw placement under fluoroscopic imaging, but with recent technologic advances, intraoperative 3d navigation can now be used to help with the insertion of sacroiliac screws.Various cadaver studies have shown that placement of sacroiliac screws under 3d navigationis more accurate than placement under traditional fluoroscopic guidance.This retrospective review of 134 patients evaluated the clinical use of 3d navigation vs traditional fluoroscopy for sacroiliac screw insertion at an urban level i trauma center.Analysis of surgical data showed a significantly longer imaging time with the conventional method compared with the more experimental 3d navigation (204.06 seconds vs 66.90 seconds, p<(> <<)>.01).Further, a significantly larger radiation dose to both the patient and the staff was seen with traditional fluoroscopy (80.1 mgy for each) compared with that of 3d navigation (39.0 mgy and 25.1 mgy, respectively).No statistically significant difference was seen for outcome or follow-up variables between the 2 extrapolated groups.These variables included length of hospital stay, infection, nerve injury, and hardware breakage.The authors advocate that 3d navi gated sacroiliac screws are safe and effective for pelvic ring stabilization; this method may be especially applicable in certain difficult imaging situations, such as morbid obesity, bowel gas interference, and overlapping pelvic structures that make the sacral c orridor difficult to discern with traditional 2d fluoroscopy.Safe placement of transiliac-transsacral screws (p<(><<)>.01).Reported events: 1 patient with a superficial infection 1 patient with a deep infection 2 patients with foot drops 1 patient that experienced screw breakage see attached literature article.

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.

• 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: 16295986
• MDR Text Key: 309470449
• Report Number: 3004785967-2023-00072
• 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: 02/03/2023

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: 01/30/2023
• Initial Date FDA Received: 02/03/2023
• 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: 37 YR
• Patient Sex: Male