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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  Injury  

Event Description

Arnold b.Vardiman, david j.Wallace, grant a.Booher, nader toossi, and brandon s.Bucklen.Decreasing the pedicle screw misplacement rate in the thoracic spine with robot-guided navigation.Clin spine surg 2023;00:000¿000.Objective: the aim of this study was to evaluate the screw accuracy of thoracic pedicle screws placed with a robot-guided navigation system.Summary of background data: thoracic pedicles are smaller in diameter than lumbar pedicles, making pedicle screw placement difficult.Misplaced pedicle screws may present complications including decreased construct stability, and increased risks of neurological deficits and blood vessel perforation.There is a dearth of knowledge on thoracic pedicle screw accuracy placed with a robot.Materials and methods: a retrospective analysis of the robot assisted placement of thoracic pedicle screws was performed.Preoperative and postoperative computed tomography (ct) scans of the implanted thoracic screws were collected to assess screw placement accuracy, pedicle breadth, and placement deviations.A ct-based gertzbein and robbins system was used to classify pedicle screw accuracy in 2 mm increments.A custom image overlay software was used to determine the deviations between the preoperatively planned trajectory of pedicle screws and final placement at screw entry (tail), and tip in addition to the angular deviation.Results: seventy-five thoracic pedicle screws were implanted by navigated robotic guidance in 17 patients, only 1.3% (1/75) were rep ositioned intraoperatively.Average patient age and body mass index were 57.5 years and 25.9 kg/m2, respectively, with 52.9% female patients.Surgery diagnoses were degenerative disk disease (47.1%) and adjacent segment disease (17.6%).There were zero complications, with no returns to the operating room.According to the ct-based gertzbein and robbins pedicle screw breach classification system, 93.3% (70/75) screws were grade a or b, 6.6% (5/75) were grade c, and 0% were grade d or e.The average deviation from the preoperative plan to actual final placement was 1.8±1.3 mm for the screw tip, 1.6± 0.9 mm for the tail, and 2.1± 1.5 degrees of angulation.Conclusions: the current investigation found a 93.3% accuracy of pedicle screw placement in the thoracic spine.Navigated robot assistance is a useful system for placing screws in the smaller pedicles of the thoracic spine.Reported events.- of the 75 screws, only 1.3% (1/75) were misplaced and repositioned intraoperatively.

Manufacturer Narrative

A2.Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.A3.Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.B3.Please note that this date is based off the date of publication of the article as the actual event date was not provided.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.

Manufacturer Narrative

H2) additional information was added to b5.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

Additional information was received stating that none of the medtronic devices were investigated in this study.

Manufacturer Narrative

Correction.Mfr name and address updated to the correct one.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 CO 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton,ma CO 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17501929
• MDR Text Key: 321045604
• Report Number: 1723170-2023-01438
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• 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: 08/17/2023
• 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: 57 YR
• Patient Sex: Female