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 Fever (1858); Unspecified Infection (1930)

Event Date 03/15/2023

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

Kim, j.H., jitpakdee, k., kotheeranurak, v., quillo-olvera, j., choi, k.C., kim, y.J., lee, c.R., kim, j.S.Is navigation beneficial for transforaminal endoscopic lumbar foraminotomy? a preliminary comparison study with fluoroscopic guidance.Eur spine journal.(2023).(1-11) https://doi.Org/10.1007/s00586-023-07624-5 abstract purpose the primary purpose of this study was to determine radiation exposure of the surgeon during transforaminal endoscopic lumbar foraminotomy (telf).Secondary purpose of this study was to compare clinical and radiologic outcomes between telf under c-arm fluoroscopic guidance (c-telf) and o-arm navigation-guided telf (o-telf).Methods the author reviewed patients¿ medical records who underwent telf at our institute from june 2015 to november 2022.A total of 40 patients were included (18 patients with c-telf and 22 with o-telf).Basic demographic data were collected.Preoperative/postoperative visual analog scale (vas) and oswestry disability index (odi) were recorded at the outpatient clinic.Radiologic features were compared on x-rays at each follow-up.The degree of foraminal expansion was measured/compared through mri.In the c-telf group, the amount of exposure was calculated with a dosimeter.Results average surgeon's effective dose in the c-telf group was 0.036 msv.In the case of the o-telf group, there was no radiation exposure during operation.However, the operation time in the o-telf group was about 37 min longer than that in the c-telf group.There were significant improvements in vas/odi after operation in both groups.Complications were identified in three patients.Conclusion o-telf showed similarly favorable clinical and radiologic outcomes to c-telf in lumbar foraminal stenosis, including complication rate.Compared to c-telf, o-telf has an advantage of not wearing a lead apron since the operator is not exposed to radiation.However, the operation time was longer with o-telf due to o-arm setting time.Because there are pros and cons, the choice of surgical method depends on the surgeon¿s preference.Reported events: 1 patient with an infection 1 patient was discharged 2 days after the operation but was readmitted the next day due to fever.After antibiotics the patient was discharged after 6 days of additional admission 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: 16964313
• MDR Text Key: 315590637
• Report Number: 3004785967-2023-00307
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 05/18/2023

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: 04/27/2023
• Initial Date FDA Received: 05/19/2023
• 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): Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female