MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: suspect medical device references the main component of the system.Other relevant device(s) are: product id: 9735740, software version: 1.0.2.Device evaluated by mfr: no system checkout was completed due to analysis requiring an exam review.Codes b21, c21, d16 are applicable.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

Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar procedure.It was reported that the screw went medial.This occurred intraoperatively, and there was a surgical delay of less than one hour.There was no reported impact to patient outcome.Additional information was received.There was approximately 4-7 mm of inaccuracy during navigation, and it was more inaccurate the further from the reference frame.The surgeon planned on putting in bilateral pedicle screws but only placed screws unilaterally.The surgery was aborted post anesthesia, and post incision.The two screws that were placed went medial into the spinal canal.Both screws were revised with a second spin with the imaging system and navigation.Additional information was received.The cas was a single position prone lateral with alphatec, with an alphatec spine representative present.No medtronic representation was present during this incident.The imaging system was brought in to spin after the cage was placed for the posterior screw placement with navigation, and the spin was completed and transferred to the navigation system.The surgeon placed two screws on the ipsilateral side, and noticed on the x-ray that screws did not appear to be where the navigation was showing.They brought the imaging system back in andspun a second time, and confirmed that both of the screws had a medial breach of the pedicle.With the new spin from the imaging system, they assumed that the navigation would be accurate again, they removed the screws and repositioned the screws using the navigation and imaging system.The site tried navigating the contralateral side and again noticed that the navigation appeared accurate but the imaging system was showing that the trajectory was going to go medial again.The navigation was accurate from cephalad to caudal and confirmed with imaging system, however, on the first spin the navigation was medial on the right side and on the second spin the navigation was medial on the left side.The navigation was aborted after the second time, and only unilateral screws were placed in the patient.

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.

Manufacturer Narrative

H3, h6: software analysis was completed and the site did registration with the help of the imaging system, but the logs did not capture any abnormality related to the reported behavior.There is insufficient information to determine root cause of reported behavior.Software logs are not helpful in diagnosing auto-registration accuracy issues.Frame movement after registration is a common cause of accuracy issues but cannot be detected in logfiles or archives.B01, c19 and d15 are applicable.H3, h6: system service wasn't completed.B17, c20, d15 are applicable.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: STEALTHSTATION¿ S8 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16334949
• MDR Text Key: 309153197
• Report Number: 1723170-2023-00190
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2019
• 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; Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 122 KG