MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MAZOR X STEALTH EDITION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number TPL0059

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

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 guidance system being used during a spinal procedure.It was reported that four of the seven implants were off.There was no impact on the patient outcome.Additional information was received stating that trajectories were deviated between 3.5 and 10mm.There was no surgical delay.The cause of the deviation was unknown at the time.

Manufacturer Narrative

H2) additional information: see b5.H3) the investigating team has reviewed all available information and concluded the root cause of the deviations to be inadequate fixation platform, most probably leading to a platform shift after instrumenting l3 left.As for the navigation module, the investigating team has concluded that the root cause of the mismatch was due platform movement along with the robotic reference frame in relation to the patient, making the deviations not displayed on the navigation screen while instrumenting deviated trajectories.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 received from a manufacturer representative reported that they believed the pins were not inserted deep enough.The surgical bed was not changed during the procedure after registration was completed.The surgeon was no leaning on the patient and the retractors were not moved or altered during the procedure.Typically the surgeon started on the left side of the patient and switches to the right.

• Brand Name: MAZOR X STEALTH EDITION
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9583081
• MDR Text Key: 175391747
• Report Number: 1723170-2020-00131
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109183213
• UDI-Public: 07290109183213
• Combination Product (y/n): N
• PMA/PMN Number: K182077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 74