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 Muscle Weakness (1967); Pain (1994); Numbness (2415)

Event Date 11/09/2022

Event Type  malfunction  

Event Description

(b)(6).Simultaneous anterior posterior approach for single-position lateral lumbar interbody fusion with robotic assistance: technical guidelines and early outcomes.World neurosurgery.2022 (e1-e6) https://doi.Org/10.1016/j.Wneu.2022.11.038 background: lumbar lateral interbody fusion (llif) is traditionally performedin 2 stages: placing the interbody cage in the lateral decubitus position, then placing the percutaneous pedicle screw in the prone position.Performing interbody fusion and posterior fixation simultaneously could improve operative efficiency and clinical outcomes associated with longer operative times.We describe the operative steps and report clinical and radiographic outcomes associated with a simultaneous anterior and posterior approach (sapa) for llif.Methods: patients who underwent sapa llif performed by a single surgeon over 1 year were retrospectively reviewed.Demographic, clinical, and radiographic data were analyzed, an operative guideline was created, and a learning curve was constructed using operative times.Results: sapa llif was performed in 11 patients.Three patients experienced transient postoperative femoral nerve plexopathy with sy mptoms of ipsilateral hip flexion weakness and/or anterior thigh numbness; there were no other complications in the cohort.Radiographically, patients achieved significant increases in disc height (8.3 mm vs.13.5 mm, p [ 0.002) and foraminal height (20.2 mm vs.25.3 mm, p [ 0.0001).Patients showed significant improvements in oswestry disability index (52 vs.27.8, p [ 0.002) and patient-reported outcome measurement information system physical function (32.6 vs.39, p [ 0.048) and pain interference (64.9 vs.59.6, p [ 0.001) at 3 months.A downward trend in operative time was observed for 1- level sapa llif.Conclusions: sapa llif is a safe approach for llif that results in favorable clinical outcomes.This technique can potentially improve operative efficiency further along the course of a surgeon¿s learning curve.Reported events: one patient who underwent atp approach at l3-4 had 4/5 hip flexion weakness without sensory disturbance that resolved at 1-month follow-up.A second patient had 4/5 hip flexion and knee extension weakness with anterior thigh pain after surgery at l4-5 via transpsoas approach.The patient¿s weakness improved to near normal (4þ/5) by postoperative day 3, and the anterior thigh pain slowly improved.The third patient had anterior thigh pain that significantly improved by 3 months with only mild residual anterior thigh numbness after a transpsoas approach at l2-3.See attached literature article.

Manufacturer Narrative

Patient age is the mean value of patients in the study.A patient gender is the majority value of patient in the study patient weight not available from the site.Event date is the accepted date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.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.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: 15969775
• MDR Text Key: 307270703
• Report Number: 3004785967-2022-00826
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2022

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: 12/09/2022
• Initial Date FDA Received: 12/13/2022
• 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 Age: 55 YR
• Patient Sex: Female