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

Model Number TPL0059

Device Problems Imprecision (1307); Unintended Movement (3026)

Patient Problems Cerebrospinal Fluid Leakage (1772); Bone Fracture(s) (1870); Pain (1994)

Event Date 07/25/2022

Event Type  Injury  

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that there was an alleged inaccuracy on (b)(6).It was reported that multiple screws were determined to be medially off via post-op scan.The site registered via a ct to fluoro  merge with a percutaneous pin in the psis.  the screws were placed accurately bilaterally at all levels per the robotic plan.T8-l1 were then registered via ct to fluoro merge with the bone mount clamp at approximately t10-t11.The screws were placed accurately.The final three levels t5-t7 were registered the same way with the bone mount clamp on t7.When beginning to place the first screw at t7, there was a shoulder shift error.The robot was registered again without moving the clamp and, again, when the site started placing the t7 screw, they received a shoulder shift error.The clamp was removed, and it was noticed that the spinous process had cracked.The clamp was moved up one level to t6, and the robot registered one last time to place the screw bilaterally up to t5.No intra-operative imaging was taken to confirm the screw placement.The patient was in some pain post operatively.When it was discovered a different patient had mispositioned screws and needed revision, this patient was brought back into the hospital and ct imaging was performed.It was at this time that the screws placed at t5-t7 were found to be mispositioned.The patient underwent another procedure on (b)(6) 2022 utilizing hooks to revise the inaccuracy.There was evidence of a dural csf leak.Duraseal was applied.As of (b)(6), the patient was neurologically intact.No delay was reported.

Manufacturer Narrative

Other relevant device(s) are: product id: un k_mazorx_shlder.No parts were returned for 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: a software analysis was conducted.It was determined based on the provided logs/exports that the root cause of the deviations experienced in the operating room is soft-tissue pressure applied on the tools while instrumenting, resulting in medially deviated t5-t7 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.

• 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: 15401346
• MDR Text Key: 299670961
• Report Number: 3005075696-2022-00066
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109184838
• UDI-Public: 07290109184838
• 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: 09/29/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 59 KG