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 Problem Bacterial Infection (1735)

Event Date 01/29/2022

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal entry.This value reflects the mean age of the patients who underwent the spinal procedure as specific patients could not be identified.This value reflects the majority gender of the patients who underwent the spinal procedure as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the published online date.The article citation is included.The imaging system was an o-arm.The system product number and serial number were not provided in the journal article.Udi not available for this system.No 510k provided as system is unknown.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

Kumagai, g., wada, k., tanaka, s., asari, t., nitobe, y., <(>&<)>amp; ishibashi, y.(2022).Association between intraoperative computed tomography navigation system and incidence of surgical site infection in patients with spinal surgeries: a retrospective analysis.Journal of orthopaedic surgery and research, 17(1).Https://doi.Org/10.1186/s13018-022-02936-6 summary purpose: although the use of intraoperative computed tomography (ct)-based navigation systems is unlikely to cause intraoperative co ntamination more than the use of intraoperative fluoroscopy, the association between intraoperative ct/navigation and surgical site infections (ssis) remains unclear.We investigated the incidence of ssis and the association between intraoperative ct/navigation and ssis for spinal surgeries.Methods: of the 512 patients who underwent spinal surgery between april 2016 and december 2020, 304 underwent c-arm intraoperative fluoroscopy and/or medtronic o-arm intraoperative ct/navigation system.We investigated the incidence of ssis in patients with four techniques; no intraoperative imaging c-arm only, o-arm only, and both o- and c-arm used.Multivariate logistic analyses were conducted using the prevalence of ssis as the dependent variable.The independent variables were age, sex, and potential confounders including preoperative japanese orthopaedic association (joa) score, use of instrumentation, c-arm, and/or o-arm.Results: the incidence of the ssis in patients with no imaging, c-arm only, o-arm only, and both modalities used was 1.9%, 7.3%, 4.7%, and 8.3%, respectively.There was no significant difference in the incidence of ssis between the four techniques.Multivariate logistic analyses showed a significant correlation between the prevalence of ssi and joa scores (odds ratio, 0.878; 95% ci 0.759¿0.990) and use of instrumentation (odds ratio, 6.241; 95% ci 1.113¿34.985), but not use of o-arm.Conclusions: the incidence of the ssis in patients with only o-arm used was 4.7%.Preoperative clinical status and use of instrumentation, but not use of the o-arm, were associated with ssis after spinal surgeries.Reported events two hundred and forty nine patients with various histology underwent spinal surgery.Thirteen patients experienced surgical site infection, six superficial and seven deep.Of these infections two were propionibacterium acnes, three were methicillin-sensitive coagu lase-negative staphylococci, four were methicillin-resistant coagulase-negative staphylococci, and one was methicillin-resistant staphylococcus aureus.The superficial infections were resolved with antibiotics, but additional surgery and antibiotics were required to resolve the deep infections.

Manufacturer Narrative

D1, d4, g2, g4, h4: the product and serial number were provided by the manufacturer representative.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: 13720251
• MDR Text Key: 286932552
• Report Number: 3004785967-2022-00171
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

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: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2016
• 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; Other
• Patient Age: 63 YR
• Patient Sex: Female