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 Bone Fracture(s) (1870); Muscle Weakness (1967); Pain (1994); Numbness (2415); Insufficient Information (4580)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal entry age or date of birth: this value reflects the average age of the patients who underwent the lateral single-position surgery as specific patients could not be identified.Sex: this value reflects the majority gender of the patients who underwent the lateral single-position surgery as specific patients could not be identified.Date of event: the article did not provide the date of the procedure.The event date provided is the accepted date.The article citation is included.The serial number was not provided in the journal article.No evaluation was performed as the event was reported as a literature article.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Hiyama, akihiko, et al.¿intraoperative computed tomography-guided navigation versus fluoroscopy for single-position surgery after lateral lumbar interbody fusion.¿ journal of clinical neuroscience, vol.93, 2021, pp.75¿81., https://doi.Org/10.1016/j.Jocn.2021.08.023.Summary there are no reports comparing fluoroscopy and intraoperative computed tomography (ct) navigation in lateral single-position surgery (sps) in terms of surgical outcomes or implant-related complications.Therefore, the purpose of this study was to use radiological evaluation to compare the incidence of instrument-related complications in sps of lateral lumbar interbody fusion (llif) using fluoroscopy with that using ct navigation techniques.We evaluated 99 patients who underwent lateral sps.Twenty-six patients had a percutaneous pedicle screw (pps) inserted under fluoroscopy (sps-c group), and 73 patients had a pps inserted under intraoperative ct navigation (sps-o group).Average operation time was shorter in the sps-c group than in the sps-o group (88.4 ± 24.4 min versus 111.9 ± 35.3 min, respectively, p = 0.003).However, there was no significant difference between the two groups in postoperative thigh symptoms or reoperation rate.The screw insertion angle of the sps-c group was smaller than that of the sps-o group, but there was no significant difference in the rate of screw misplacement (4.6% versus 3.4%, respectively, p = 0.556).By contrast, facet joint violation (fjv) was significantly lower in the sps-o group than in the sps-c group (8.4% versus 21.3%, respectively, p <(><<)> 0.001).While fluoroscopy was superior to intraoperative ct navigation in terms of mean surgery time, there was no significant difference in the accuracy of pps insertion between fluoroscopy and intraoperative ct navigation.The advantage of intraoperative ct navigation over fluoroscopy is that it significantly decreases the occurrence of fjv in sps.Reported events: 73 patients with lumbar degenerative disc disease and degenerative lumbar spondylolisthesis underwent lateral single-position surgery.Among these patients ten were found have motor weakness and 14 reported thigh pain and numbness.In regards to screw misplacement, two screws were found to breach less than two millimeters, five screws breached between two and four millimeters, and two screws breached to the extent that they caused patient complications.The article sites that these complication could be things such as a fractured pedicle, an anterior breach with neurovascular compromise, and a lateral/medial breach with neurological sequelae.It was unclear from the article what complications were associated with each screw.Eighteen screw heads were in contact/suspected to be in contact with the facet joint, while seven screws invaded the facet joint.There were five reoperations, three being due to instrument related complications such as pps deviation and cage malposition.See attached article.

Manufacturer Narrative

H2) the system serial number was received.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 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: 12814773
• MDR Text Key: 281839947
• Report Number: 3004785967-2021-01285
• 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,Followup
• Report Date: 04/01/2022

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: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 04/01/2022
• 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): Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 62 KG