MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR X SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number TPL0059

Device Problems Imprecision (1307); Mechanical Problem (1384); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that there was a case of an alleged inaccuracy while using scan and plan and stealth navigation in a t9 through l1 spine case, skipping t11.The first trajectory was on t9-l but looked lateral in navigation.They tested the accuracy by touching the divot on the arm guide and found the tracker to be about 1 mm off.They took new snapshots and rechecked the divot, finding it accurate.They also verified accuracy by checking the accuracy on the patient; however, t9-l still showed too lateral, but the surgeon deemed the trajectory acceptable.The surgeon tapped and drilled the first trajectory.However, while waiting for a specific screw to be brought into the operating room, surgery proceeded to the subsequent trajectory on t9-r.T9-r showed medial, so the surgeon didn't feel comfortable continuing the surgery.The manufacturer representative removed the guidance system from the bed, tested the navigation, and it showed to be accurate.The surgeon decided to freehand the last 7 trajectories using midas.A post-op spin was performed, and the surgeon deemed the screw placements acceptable.The manufacturer representative took pictures of the t9-r plan and imaging system scan, showing an accurate placement of the screw.The delay was approximately 10 minutes.There was no impact on the patient outcome.A target extender was delivered to the account and was allegedly damaged.The target extender did not sit flush with the 3d marker.The damaged target extender was believed to be the root cause of the inaccuracy.The c-arm expects to see the 3d marker in a specific spot, so the case will be inaccurate if the 3d marker is a little off on the target extender.The target extender was not seating well in the holes.The holes were too small and it felt like it was fully seated when in fact it was not.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: mas2310, serial/lot : (b)(6) h3, h6: the exports were returned for clinical analysis.The analysis confirmed that the issue was likely due to a faulty target extender.B01, c07, d02 are applicable to the clinical analysis.The target extender has been returned for analysis.The analysis is still in progress.B21, c21, d16 are applicable to the product analysis.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: the target extender was returned for product analysis.The analysis determined that no failures were found.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: MAZOR X SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17247652
• MDR Text Key: 318677577
• Report Number: 3005075696-2023-00038
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290115751376
• UDI-Public: 07290115751376
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182077
• 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
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• 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: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• 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 Age: 80 YR
• Patient Sex: Male
• Patient Weight: 86 KG