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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

Event Description

Ohba, t., oda, k., tanaka, n., haro, h.The utility and appropriateness of single-position circumferential lumbar interbody fusion using o-arm-based navigation in the novel oblique position.Journal of clinical medicine.2023, 12, 7114.Https://doi.Org/10.3390/jcm12227114 purpose: single-position surgery with patients in a lateral position, which involves inserting percutaneous pedicular screws (pps) and lateral interbody fusion (lif) to avoid changing the position, has been reported.The purpose of the present study was to evaluate the utility and appropriateness of single-position lif-pps using o-arm-based navigation in the innovative oblique position.Methods: this study involved a retrospective analysis of 92 consecutive patients with lumbar spondylolisthesis who underwent lif-pps using o-arm-based navigation.Thirty-five subjects demonstrated surgery with repositioning, as well as 24 in the lateral decubitus position, and 33 in the oblique during pps, where the position was changed to the lateral decubitus position using bed rotation without resetting.We compared these three groups in terms of the surgery time, blood loss, and the accuracy of the screw placement.Results: the operative time was significantly shorter in the single-position surgery, both in the lateral and oblique positions, com pared to surgery in a dual position.The blood loss was significantly increased in the lateral position compared to the dual and oblique positions.The screw trajectory angle on the downside was significantly smaller in the lateral position, and the accuracy of the screw placement on the downside was significantly lower in the lateral position compared to the dual and oblique positions.Conclusion: single-position surgery could reduce the average surgery time by about 60 min.The present study indicated the oblique position during pps insertion might make single-position surgery more useful to improve the accuracy of pps on the downside, with less blood loss.Reported events: lower accuracy for pps downside placement in the ld group see attached literature article.

Manufacturer Narrative

A1-a5) patient information was unavailable from the site.B3) event date is the online publishing date of the literature article.D4) device lot number, or serial number, unavailable.G4) 510(k) is dependent upon the device model number and therefore, unavailable.H3,h6) no parts have been received by the manufacturer for evaluation.H4) 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: 18645459
• MDR Text Key: 336056452
• Report Number: 3004785967-2024-00083
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/05/2024

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: 02/01/2024
• Initial Date FDA Received: 02/05/2024
• 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