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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/29/2023

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.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

Cammarata, g., scalia, g., costanzo, r., umana, g.E., furnari, m., ponzo, g., giuffrida, m., maugeri, r., lacopino, d.G., nicoletti, g.F., graziano f.Fluoroscopy-assisted freehand versus 3d-navigated imaging-assisted pedicle screw insertion: a multicenter study.The funnel: from the skull base to the sacrum.Acta neurochirurgica supplement, vol 135.Springer, cham.Https://doi.Org/10.1007/97 8-3-031-36084-8_65 vertebral fusion performed by segmented pedicle screw fixa-tion is a globally well-established method to restore spine stability, preserve neurological function, and relieve pain and neurological symptoms.Pedicle screw fixation improves and restores the stability of spine biomechanics in patients with traumatic vertebral fractures, degenerative disease (stenosis/spondylolisthesis), neoplastic disease (primary or second-ary), infective disease (spondylodiscitis), or spine deformi-ties [1].Potential errors in screw placement implies muscular, bone, vascular, or neuronal lesions, resulting in major or minor complications, from postoperative pain or neurologi-cal deficits up to life-threatening conditions, such as vascular complications [2].The intraoperative control provided by using a c-arm fluoroscope was one of the first techniques to assess screw trajectory, obtaining 2d image projections.However, a high rate of misplacement, from 14% to 40%, has been reported [3¿5].One of the latest techniques developed to further lower the misplacement rate is the three-dimensional (3d) cone- beam computed tomography (ct) o-arm (medtronic navigation, louisville, co, usa), which allows for the intraoperative 3d acquisition of vertebral images.The 3d images can be used by the neuronavigation system, stealthstation (medtronic navigation, louisville, co, usa), which provides direct 3d path control for screw placement.This is a retrospective, multicenter study evaluating the mispositioning rate of 1288 peduncular screws in a popula-tion of 222 patients, screws that were placed with the free-hand technique thanks to c-arm assistance and the o-arm ii complete multidimensional surgical imaging system (medtronic navigation, louisville, co, usa), coupled with the stealthstation navigation system (medtronic navigation, louisville, co, usa).Reported events: in 12 patients, cortical pedicular rupture occurred (10.43%), for a total of 12 misplaced screws (1.87%) two cases with revision surgery required.Four screws (0.62%) ruptured the vertebral cortical anterior body, and in eight cases, the screws were lateralized 11 screws were grade b and one was grade c.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: 18859559
• MDR Text Key: 337181048
• Report Number: 3004785967-2024-00145
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/07/2024

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: 03/04/2024
• Initial Date FDA Received: 03/07/2024
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female