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 Imprecision (1307)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 12/30/2022

Event Type  malfunction  

Event Description

Kim, h.C., jeong, y.H., oh, s.H., lee, j.M., lee, c.K., yi, s., ha, y., kim, k.N., shin, d.A.Single-position oblique lumbar interbody fusion and percutaneous pedicle screw fixation under o-arm navigation: a retrospective comparative study.Journal of clinical medicine.2023.12 (312-323).Https:// doi.Org/10.3390/jcm12010312 abstract: the insertion of pedicle screws in the lateral position without a position change has been reported.We completed a retrospective comparison of the radiologic and clinical outcomes of 36 patients who underwent either single-position oblique lateral lumbar interbody fusion (sp-olif) using the o-arm (36 cases) or conventional olif (c-olif) using the c-arm (20 cases) for l2¿5 single-level lumbar degenerative diseases.Radiological parameters were analyzed, including screw accuracy (gertzbein-robbins classification system; grs), segmental instability, and fusion status.Screw misplacement was defined as a discrepancy of =2 mm.Clinical outcomes, including visual analog scale, oswestry disability index (odi), 36-item short form health survey (sf-36), and postoperative complications, were assessed.The spinal fusion rate was not different between the sp-olif and c-olif groups one year after surgery (p = 0.536).The odi score was lower (p = 0.015) in the sp-olif than the c-olif group.Physical (p = 0.000) and mental component summaries (p = 0.000) of the sf-36 were significantly higher in the sp-olif group.Overall complication rates, including revision, surgical site infection, ipsilateral weakness, and radicular pain/numbness, were not significantly different.Sp-olif using the o-arm procedure is feasible, with acceptable accuracy, fusion rate, and complication rate.This may be an alternative to conventional two-stage operations.Reported events: five screws (3.5%) as grade b there was one case (2.8%) of motor weakness in the sp-olif group, foot drop occurred immediately after surgery but completely recovered two weeks later.The number of patients complaining of temporary radicular pain and numbness was three (8.3%) in the sp-olif group.

Manufacturer Narrative

Patient age: patient age is the mean value of patients in the study.Sex: patient gender is the majority value of patient in the study.Weight: patient weight not available from the site.Date of event: event date is the online publishing date of the literature article.Serial number: device lot number, or serial number, unavailable.Pma/510k: 510(k) is dependent upon the device model number and therefore, unavailable.H3,h6) no parts have been received by the manufacturer for evaluation.Device manufacture date: 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: 16498095
• MDR Text Key: 311296795
• Report Number: 3004785967-2023-00145
• 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: 03/07/2023

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: 02/27/2023
• Initial Date FDA Received: 03/07/2023
• 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 Age: 62 YR
• Patient Sex: Female