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 Problems Unspecified Infection (1930); Unspecified Tissue Injury (4559)

Event Date 08/13/2023

Event Type  Injury  

Manufacturer Narrative

A2) patient age is the mean value of patients in the study.A3) patient gender is the majority value of patient in the study.A4) patient weight not available 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.

Event Description

Haemmerli, j., ferdowssian, k., wessels, l., mertens, r., hecht, n., woitzik, j., schneider, u., bayerl, s., vajkoczy, p., czabanka, m.Comparison of intraoperative ct- and cone beam ct-based spinal navigation for the treatment of atlantoaxial instability.The spine journal 23 (2023) 1799-1807.Https://doi.Org/10.1016/j.Spinee.2023.08.010 background context: due to the complexity of neurovascular structures in the atlantoax-ial region, spinal navigation for posterior c1-c2 instrumentation is nowadays a helpful tool to increase accuracy of surgery and safety of patients.Many available intraoperative navigation devi-ces have proven their reliability in this part of the spine.Two main imaging techniques are used: intraoperative ct (ict) and cone beam computed tomography (cbct).Purpose: comparison of ict- and cbct-based technologies for navigated posterior instrumen-tation in c1-c2 instability.Study design: retrospective study.Patient sample: a total of 81 consecutive patients from july 2014 to april 2020.Outcome measures: screw accuracy and operating time.Methods: patients with c1-c2 instability received posterior instrumentation using c2 pedicle screws, c1 lateral mass or pedicle scre ws.All screws were inserted using intraoperative imaging either using ict or cbct systems and spinal navigation with autoregistration technology.Following navi-gated screw insertion, a second intraoperative scan was performed to assess the accuracy of screw placement.Accuracy was defined as the percentage of correctly placed screws or with minor cortical breach (<(><<)>2 mm) as graded by an independent observer compared to misplaced screws.Results: a total of 81 patients with c1-c2 instability were retrospectively analyzed.Of these, 34 patients were operated with the u se of ict and 47 with cbct.No significant demographic difference was found between groups.In the ict group, 97.7% of the c1-c2 screws were correctly inserted; 2.3% showed a minor cortical breach (<(> <<)>2 mm); no misplacement (>2 mm).In the cbct group, 98.9% of screws were correctly inserted; no minor pedicle breach; 1.1% showed misplacement >2 mm.Accuracy of screw placement demonstrated no significant difference between groups.Both technologies allowed sufficient identification of screw misplacement intraoperatively leading to two screw revisions in the ict and three in the cbct group.Median time of surgery was significantly shorter using cbct technology (166.5 minutes [ict] vs 122 minutes [cbct]; p<(><<)>.01).Conclusions: spinal navigation using either ict- or cbct-based systems with autoregistra-tion allows safe and reliable screw placement and intraoperative assessment of screw positioning.Using the herein presented procedural protocols, cbct systems allow shorter operating time.© 2023 elsevier inc.All rights reserved.Reported issues: 3 patients with vertebral artery lesions 1 wound infection 3 patients with intraoperative screw revisions 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: 18659161
• MDR Text Key: 334757360
• Report Number: 3004785967-2024-00090
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/07/2024

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?: 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: 01/26/2024
• Initial Date FDA Received: 02/07/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female