MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Post Operative Wound Infection (2446); Unspecified Nervous System Problem (4426); Unspecified Tissue Injury (4559)

Event Date 11/03/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Hiyama, a., sakai, d., katoh, h., nomura, s., watanabe, m.Assessing procedural accuracy in lateral spine surgery: a retrospective analysis of percutaneous pedicle screw placement with intraoperative ct navigation.Journal of clinical medicine.2023.12 6914.Http s://doi.Org/10.3390/jcm12216914 abstract: percutaneous pedicle screws (ppss) are commonly used in posterior spinal fusion to treat spine conditions such as trauma, tumors, and degenerative diseases.Precise pps placement is essential in preventing neurological complications and improving patient outcomes.Recent studies have suggested that intraoperative computed tomography (ct) navigation can reduce the dependence on extensive surgical expertise for achieving accurate pps placement.However, more comprehensive documentation is needed regarding the procedural accuracy of lateral spine surgery (lss).In this retrospective study, we investigated patients who underwent posterior instrumentation with ppss in the thoracic to lumbar spine, utilizing an intraoperative ct navigation system, between (b)(6) 2023.The system¿s methodology involved real-time ct-based guidance during pps placement, ensuring precision.Our study included 170 patients (151 undergoing llif procedures and 19 trauma patients), resulting in 836 pps placements.The overall pps deviation rate, assessed using the ravi scale, was 2.5%, with a notably higher incidence of deviations observed in the thoracic spine (7.4%) compared to the lumbar spine (1.9%).Interestingly, we found no statistically significant difference in screw deviation rates between upside and downside pps placements.Regarding perioperative complications, three patients experienced issues related to intraoperative ct navigation.The observed higher rate of inaccuracies in the thoracic spine suggests that various factors may contribute to these differences in accuracy, including screw size and anatomical variations.Further research is required to refine pps insertion techniques, particularly in the context of lss.In conclusion, this retrospective study sheds light on the challenges associated with achieving precise pps placement in the lateral decubitus position, with a significantly higher deviation rate observed in the thoracic spine compared to the lumbar spine.This study emphasizes the need for ongoing research to improve pps insertion techniques, leading to enhanced patient outcomes in spine surgery.Reported events: 3 ict-related problems 1 surgical site infections 2 postoperative neurological deficit (pps-related) 6 reoperation see attached literature article.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: 18580733
• MDR Text Key: 333772583
• Report Number: 3004785967-2024-00051
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200074
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2019
• 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): Required Intervention