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

Model Number TPL0059

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Cerebrospinal Fluid Leakage (1772); Muscle Weakness (1967); Paraplegia (2448)

Event Date 02/05/2024

Event Type  malfunction  

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that during the t6-t9 spinal fusion, using scan and plan registration, three screws (left t6, t9 and t8) were medial and breached (noted on the post-op medtronic imaging scan).The left t6 screw made contact with the spinal cord and a cerebrospinal fluid (csf) leak was noticed.It was noticed at the end of the case.The surgeon doublechecked the laminectomy and removed the t6 left screw and noticed the csf leak under the microscope.The patient was paralyzed and had poor bone quality, therefore, all-tip screws used were to mitigate skive potential.The surgeon was standing on both sides of the patient - stood on left to place left side screws and stood on the right to place the right side screws.All of the left side screws were removed and not replaced.There was troubleshooting present post-case.It was reported that the advanced accuracy test passed as well as the stress test.There was no surgical delay time.Additional information received from a manufacturer representative indicated that the patient was reporting deficits in both legs.

Manufacturer Narrative

H3, h6) the system was serviced in the field and the manufacturer representative (rep) tightened the surgeon screen collar screws.Codes b01, c07, and d02 are applicable.H3, h6) software data has been returned for analysis.Codes b21, c21, and d16 are applicable.H1) the type of report is considered a malfunction and a serious injury.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

H2) additional information in b5.H2) updates made to additional codes.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.

Event Description

Additional information received indicated that the patient underwent an additional surgery to look around for more csf leaks and none were found to the manufacturer representative's knowledge.

Event Description

Additional information received indicated that the alleged deviation was less than 3.5 millimeters (mm).

Manufacturer Narrative

H3, h6, d9) analysis was performed for the software data that was received and analysis confirmed the reported event.From the log files and plans made for the case, all planned trajectories were planned with no observable issues.A slight medial deviation was observed for the left t7 trajectory.According to the intraoperative imaging scan, all left trajectories were medially deviated.According to the 3d reconstruction model, the midline incision was far from the plan of the left trajectories' entry points compared to the right side.Therefore, it was likely that left t6, t7, t8, and t9 were subjected to soft-tissue pressure on the tools while instrumenting.According to the order of execution, it was shown that the left side was handled first, starting at t6, followed by the right side, starting at t6.The possibility of platform or patient shifts was unlikely, as trajectories executed after the deviated trajectories were reported to be accurate.It was reported that a clamp was mounted on t9.However, it was recommended to use a single or dual clamp in the vicinity of the operated vertebrae (up to 2 vertebrae above or below) to ensure a stable platform.Therefore, for t6, the platform usage was off-label and could not be controlled for any movements or instabilities, and since t6 left was the first trajectory to be executed, the platform stability was compromised from the start and carried on to the next trajectories.While it was less likely to be the main cause of the reported inaccuracy as the inaccuracy was pertaining to the left side only, the off-label usage of the clamp in an open procedure may have contributed to the deviation.The root cause of the reported inaccuracy was soft-tissue pressure applied on the tools while instrumenting.Additionally, the off-label usage of the clamp in an open procedure may have contributed to the deviation.Previously reported codes b01 / d02 are applicable to this analysis, as well as newly reported codes: d11 and c13.H2) additional information in section b5.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.

• Brand Name: MAZOR X SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18668926
• MDR Text Key: 334909003
• Report Number: 3005075696-2024-00017
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/27/2024

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
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/08/2024; 02/16/2024
• Supplement Dates FDA Received: 02/16/2024; 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 54 KG