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 Cerebrospinal Fluid Leakage (1772); Intracranial Hemorrhage (1891); Unspecified Infection (1930)

Event Date 07/25/2023

Event Type  Injury  

Event Description

Tang, y., li, h., zhang, s., liu, h., zhang, j., yang, h., zhang, k., wang, g., chen, k.Comparison of anterior cervical discectomy fusion combined with lateral mass screw and with cervical pedicle screw fixation surgery under o-arm navigation for single-stage management of severe lower cervical fracture dislocation.Orthopaedic surgery.2023.15(2647¿2655) doi: 10.1111/os.13868 objective: the incidence of severe lower cervical fractures and dislocations due to trauma has increased significantly, and the optimal treatment remains controversial.This study compares the safety and efficacy of anterior cervical dis-cectomy fusion (acdf) combined with lateral mass screw (lms) and with cervical pedicle screw (cps) fixation surgery under o-arm navigation as single-stage treatments of severe lower cervical fracture dislocations.Methods: data from 48 patients who underwent acdf + cps (group a) or acdf + lms (group b) for severe lower cervi-cal fracture dislocation between january 2016 and september 2020 were retrospectively reviewed.Groups a and b com-prised 25 and 23 cases, respectively.Clinical parameters, such as operative time, intraoperative blood loss, number of fixed segments, posterior incision length, operative complications, and hospitalization days were recorded.Preoperatively and postoperatively, the sub-axial injury classification (slic) score, the american spinal injury association (asia) impair-ment scale, and the japanese orthopaedic association (joa) score were recorded and analyzed using student¿s t-test.Results: the slic scores were 7.1 1.2 and 7.5 1.1, asia were 1.5 0.6 and 1.2 0.6, joa score improvements were 3.2 2.4 and 3.0 2.1, operative times were 282.1 91.7 and 266.5 88.2 min, intraoperative blood losses were 437.8 118.5 and 418.7 104.2 ml, fixedsegmentswere2.8 0.7 and 4.8 1.1, and lengths of posterior inci-sions were 12.7 2.8 and 13.8 3.2 cm in groups a and b, respectively.There was no significant difference between the two groups in the operative time, intraoperative blood loss, incision length, and postoperative recovery; however, group a had more fixed segments.At the final follow-up, no intraoperative or postoperative complications directly caused by the implant were present.Throughout the follow-up, all cases showed recovery and progressive improvement.Conclusion: both acdf + lms and acdf + cps under o-arm navigation can safely and effectively restore cervical vertebral sequence, fully release spinal canal compression, and promote patients¿ neurological recovery.Thus, both are effective treatments for severe lower cervical fracture dislocations.However, compared to lms, cps under o-arm navigation has shorter fixed segments and induces less trauma.Reported events: one case of a cerebrospinal fluid leak caused by dural injury occurred, resulting in delayed one-stage incision healing.6 cases of postoperative pulmonary infections 1 patient with other complications.

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 accepted 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: 18101367
• MDR Text Key: 327729168
• Report Number: 3004785967-2023-00681
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/09/2023

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?: No
• 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: 10/19/2023
• Initial Date FDA Received: 11/09/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male