MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734653

Device Problem Device Sensing Problem (2917)

Patient Problem Paralysis (1997)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

Foreign report source: (b)(6).No products have been returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that after discs dissection of the l3 and 4 under the navigation, free running electromyogram (emg) began to appear during the monitoring when the trial 8*45 was inserted, and both "mep" and "sep" began to fall, so it was changed to perform posterior lumbar interbody fusion (plif) from the posterior side instead of the anterior side.It was reported that paralysis of both lower limbs was caused by trial insertion with concave side invasion, and the postoperative condition was unknown on the day, so when confirmed at the time of this report, report of paralysis was received.There was a reported delay to the procedure of less than one hour.

Event Description

Additional information was received.It was reported that a representative was present and that navigation was verified and accurate and remained accurate during the rest of the procedure.Reference manufacturing report # 1723170-2020-02845 for previous information provided/reported on this event.

Manufacturer Narrative

H2: additional information received.B5 has been updated.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

Ime and imf codes have been added.D9/h2/h3/h6: the probe was returned and analyzed.The probe appeared to be in good condition with the exception of a small area of galling near the knuckle.Otherwise, the probe inserted into a known good tracker without issue.The location of the galling did not appear to cause an issue in relation to the tracker.No problem was found.Codes b01, c19 and d14 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.

Manufacturer Narrative

Additional information: see event.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 no inaccuracy was observed, ergo the paralysis was unrelated to an inaccuracy.It was reported that the issue occurred during an adult spinal deformity (asd) oblique lumbar interbody fusion (olif) of l2-l5.It was noted that the procedure was changed to be a posterior lumbar interbody fusion (plif) following monitoring results of free-run electromyography, motor-evoked potential (mep) and somatosenrory-evoked potential (sep) during the olif.Additionally it was noted that the concave side of the deformity was approached due to the patient's size.While conducting the procedure, the l3 and l4 intervertebral discs dissection was conducted from the side of the deformity.When the trial was inserted, the free-run electromyography began to show a change in its waveforms.Deterioration in the sep and mep were also observed.The surgeon then opted to discontinue inserting the cage from the oblique lateral.Following this, the cage was installed from the posterior side.Post-operative condition was unknown.

Manufacturer Narrative

Software analysis determined that there is insufficient information to determine whether a software anomaly contributed to the reported behavior.H6: fdm 10, fdr 213, fdc 67 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: NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10741927
• MDR Text Key: 213254430
• Report Number: 1723170-2020-02815
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9734653
• Device Catalogue Number: 9734653
• Device Lot Number: 121016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 55 YR