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 Urinary Retention (2119); Post Operative Wound Infection (2446); Tissue Breakdown (2681); Unspecified Nervous System Problem (4426); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information was not included in the journal entry.This value reflects the mean age of the patients who underwent robot-assisted lumbar pedicle screw placement (both scan-and-plan registration and ct-to-fluoroscopy registration methods) as specific patients could not be identified.This value reflects the majority gender of the patients who underwent robot-assisted lumbar pedicle screw placement (both scan-a nd-plan registration and ct-to-fluoroscopy registration methods) as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the accepted date.The article citation is included.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.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

Khan, a., soliman, m.A., lee, n.J., waqas, m., lombardi, j.M., boddapati, v., levy, l.C., mao, j.Z., park, p.J., mathew, j., lehman, r.A., mullin, j.P., & pollina, j.(2022).Ct-to-fluoroscopy registration versus scan-and-plan registration for robot-assisted insertion of lumbar pedicle screws.Neurosurgical focus, 52(1).Https://doi.Org/10.3171/2021.10.Focus21506.Summary: objective: pedicle screw insertion for stabilization after lumbar fusion surgery is commonly performed by spine surgeons.With the advent of navigation technology, the accuracy of pedicle screw insertion has increased.Robotic guidance has revolutionized the placement of pedicle screws with 2 distinct radiographic registration methods, the scan-and-plan method and ct-to-fluoroscopy method.In this study, the authors aimed to compare the accuracy and safety of these methods.Methods: a retrospective chart review was conducted at 2 centers to obtain operative data for consecutive patients who underwent rob ot-assisted lumbar pedicle screw placement.The newest robotic platform (mazor x robotic system) was used in all cases.One center used the scan-and-plan registration method, and the other used ct-to-fluoroscopy for registration.Screw accuracy was determined by applying the gertzbein-robbins scale.Fluoroscopic exposure times were collected from radiology reports.Results: overall, 268 patients underwent pedicle screw insertion, 126 patients with scan-and-plan registration and 142 with ct-to-fluoroscopy registration.In the scan-and-plan cohort, 450 screws were inserted across 266 spinal levels (mean 1.7 ± 1.1 screws/level), with 446 (99.1%) screws classified as gertzbein-robbins grade a (within the pedicle) and 4 (0.9%) as grade b (< 2-mm deviation).In the ct-to-fluoroscopy cohort, 574 screws were inserted across 280 lumbar spinal levels (mean 2.05 ± 1.7 screws/ level), with 563 (98.1%) grade a screws and 11 (1.9%) grade b (p = 0.17).The scan-and-plan cohort had nonsignificantly less fluoroscopic exposure per screw than the ct-to-fluoroscopy cohort (12 ± 13 seconds vs 11.1 ± 7 seconds, p = 0.3).Conclusions: both scan-and-plan registration and ct-to-fluoroscopy registration methods were safe, accurate, and had similar fluoroscopy time exposure overall.Reported event: one hundred and twenty-six patients underwent a pedicle screw insertion for stabilization after lumbar fusion surgery using scan- and-plan registration method.Four out of four hundred and fifty screws were < 2-mm deviation within the pedicle.

• 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: 16591065
• MDR Text Key: 311861023
• Report Number: 3004785967-2023-00167
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• 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
• Date Manufacturer Received: 03/06/2023
• 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: 59 YR
• Patient Sex: Female