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

Model Number BI70000027100

Device Problem Imprecision (1307)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system that was used during a cervical spine procedure.It was reported that the imaging and navigation systems were used to perform c2-th2 posterior decompression fusion procedure.The image was taken using the imaging system following the reference was fixed to c2.The accuracy of the first image was not good, so one image was taken using the imaging system again.The accuracy of the pointer and cervical probe was good, but it was confirmed that the stealth-midas deviated cranially by 1 to 2 mm.Therefore, a pilot hole was made with a cervical probe, if tap was performed, and the screw was inserted in left side of the c2-c5."c2/c5: pedicle screw (ps) c3/c4: paravertebral foramen screw (pvfs)" after that, it was moved to the right side and the accuracy was checked again, and the procedure was continued, and all pedicle screws were inserted on the right side of c2-5 based on the judgment of the surgeon that there was no accuracy problem.The image was taken using the imaging system including the imaging range to check the screw inserted earlier at the timing of navigating c6-th2.When checking the inserted screw, it was confirmed that the screw on the left side of c5 was in the direction of vertebral artery (va).A small amount of bleeding was confirmed when the screw was pulled out.Although the pulsation was checked when va could be observed on the left sideof c1, it was confirmed that it was not pulsating.At this point, the fusion procedure of the current day was discontinued and was switched to va stent procedure, and the procedure was completed.The fusion procedure was planned be continued at a later date.There was unused radiation.Additional information received stated that stent procedure (coil implantation) was performed due to va occlusion.It was not a blood vessel injury but an occlusion.The cause of the vascular occlusion may be the interference of the screw.Bleeding status: the amount of bleeding during the operation is unknown, but there was no apparently uncontrollable bleeding.No blood transfusion.The doctor said, "there was no problem when the pilot hole was made under the navigation, so it was considered that the direction was misunderstood when inserting the screw." future plan: since the fusion procedure ended when half the screw was inserted, if the patient recovers quickly, the fusion procedure will be continued to be performed by the end of the year.

Manufacturer Narrative

H3: software analysis was unable to determine the probable cause of the issue and if it relates to software anomaly based on the review of the information documented on record.According to complaint information, it was noted "there was no problem when the pilot hole was made under the navigation, so it was considered that the direction was misunderstood when inserting the screw." this case may be re-opened if additional information is received.H6: fdm 10, fdr 3221, fdc 4114.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/h3/h6: the system was serviced in the field and passed all tests.No failures were found.Codes b01, c19 and d14 are applicable.H2: correction - additional information added in 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

There was a delay of one hour or longer.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 11057714
• MDR Text Key: 223359350
• Report Number: 3004785967-2020-01541
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2021

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: No Information
• Device Model Number: BI70000027100
• Device Catalogue Number: BI70000027100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/29/2021; 02/15/2021
• Supplement Dates FDA Received: 02/02/2021; 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR