MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M

Model Number BI70000028120

Device Problems Imprecision (1307); Unintended Movement (3026)

Patient Problems Numbness (2415); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  Injury  

Event Description

Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that there was an alleged inaccuracy.It site reported that a safety incident occurred in a spine case where the screw was off by 1cm.The health care professional (hcp) was worried about accuracy of the navigation system and imaging system and the specific instruments used in the case.The manufacturer representative (rep) tested both systems and the exact instruments used in procedure and all components together were accurate.Invalidated home on the imaging system prior to testing accuracy.The hcp involved in the case also tested the accuracy and agreed that everything appeared to be functioning as normal.They stated that they had placed their sacroiliac screws first under the imaging system navigation, then brought in the competitors system to use fluoro navigation to place the rest of their screws.It was with the competitors system that they noticed that the screws were off.Navigation was accurate.So they believed the issue was related to the imaging system.The hcp also stated that they did a second spin with the imaging system after they saw the inaccurate screws, assuming the frame had been bumped the first time.The second spin showed the same degree o f inaccuracy, and the hcp stated they had ensured the frame had not been touched or moved for this second spin with great scrutiny.The sites biomed was also present for testing, and stated that some of the internal magnets from the track had been falling off inside the gantry.No further information is available at this time.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi-500-00186, version #: 3.2.1, ubd: , udi#: h3) the software team reviewed the complaint and determined that this was not a software issue.Complaint data investigation found the event was due to hardware issue "the site was also present for testing, and stated that some of the internal magnets from the track had been falling off inside the gantry." software functioning as designed.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.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

The manufacturer representative (rep) tested the imaging system and navigation system, and the exact instruments used in procedure and all components together were accurate.The rep did invalidate home on the imaging system prior to testing accuracy.The health careprofessional (hcp) involved in the case also tested accuracy and agreed that everything appeared to be functioning as normal.They stated that they had placed the sacroiliac screws first under o-arm navigation, then brought in the c-arm to use fluoro nav to place the rest of his screws.It was with the c-arm they noticed that their si screws was off.Navigation was accurate with the same navigation system so it is believed the issue is related the imaging system.The hcp also stated that they did a second spin with the imaging system after they saw the inaccurate screws, assuming the frame had been bumped the first time.The second spin showed the same degree of inaccuracy, and the hcp stated they had ensured the frame had not been touched or moved for this second spin with great scrutiny.The biomed was also present for testing, and stated that some of the internal magnets from the track had been falling off inside the gantry.

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.

Manufacturer Narrative

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.It was reported that the patient had some numbness, but that has since resolved.The patient is otherwise doing well.

Manufacturer Narrative

H6: imf code updated to f11 and ime code updated to e0127.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

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.It was reported that there was a minimal delay, but it was not timed.

• Brand Name: O-ARM 1000 IMAGING SYSTEM 3RD EDITION
• 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: 17182188
• MDR Text Key: 317674394
• Report Number: 3004785967-2023-00369
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K092564
• 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,Followup,Followup,Followup
• Report Date: 10/25/2023

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: BI70000028120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 06/29/2023; 10/03/2023; 10/03/2023; 10/25/2023
• Supplement Dates FDA Received: 07/17/2023; 10/06/2023; 10/13/2023; 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: "SEE H10....".
• Patient Outcome(s): Other