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

Model Number TPL0059

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Neuropathy (1983); Pain (1994); Urinary Retention (2119); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 07/15/2023

Event Type  Injury  

Manufacturer Narrative

A.1-a.5) patient information was included in the journal.A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.A.4.The patient's weight was no provided.B.3.Please note that this date is based off of the date the article was accepted as the event dates were not provided in the published literature.B5 include the article citation.D.4.The system serial number was not provided in the journal article.H.3.No evaluation was performed as the event was reported as a literature article.H.4.Device manufacturing date was unavailable.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

Hernandez, n.S., diaz-aguilar, l.D., & pham, m.H.(2023).Single position l5-s1 lateral alif with simultaneous robotic posterior fixation is safe and improves regional alignment and lordosis distribution index.European spine journal.Https://doi.Org/10.1 007/s00586-023-07841-y.Purpose: minimally invasive single position lateral alif at l5-s1 with simultaneous robot-assisted posterior fixation has technical and anatomic considerations that need further description.Methods: this is a retrospective case series of single position lateral alif at l5-s1 with robotic assisted fixation.End points included radiographic parameters, lordosis distribution index (ldi), complications, pedicle screw accuracy, and inpatient metrics.Results: there were 17 patients with mean age of 60.5 years.Eight patients underwent interbody fusion at l5-s1, five patients at l4-s1, two patients at l3-s1, and one patient at l2-s1 in single lateral position.Operative times for 1-level and 2-level cases were 193 min and 278 min, respectively.Mean ebl was 71 cc.Mean improvements in l5-s1 segmental lordosis were 11.7 ± 4.0°, l1-s1 lordosis of 4.8 ± 6.4°, sagittal vertical axis of - 0.1 ±1.7 cm°, pelvic tilt of - 3.1 ± 5.9°, and pelvic incidence lumbar¿lordosis mismatch of - 4.6 ± 6.4°.Six patients corrected into a normal ldi (50¿80%) and no patients became imbalanced over a mean follow-up period of 14.4 months.Of 100 screws placed in lateral position with robotic assistance, there were three total breaches (two lateral grade 3, one medial grade 2) for a screw accuracy of 97.0%.There were no neurologic, vascular, bowel, or ureteral injuries, and no implant failure or reoperation.Conclusion: single position lateral alif at l5-s1 with simultaneous robotic placement of pedicle screws by a second surgeon is a safe and effective technique that improves global alignment and lordosis distribution index.Reported event: seventeen patients underwent a simultaneous robotic single position surgery to address deformity or degenerative disc disease.Several complications were observed.One patient experienced urinary retention.Another patient experienced prolonged anterior incisional pain which resolved at eight weeks.A third patient's left hip flexor had pain and weakness, which was likely due to the cage placement.One patient experienced an anterior abdominal wall hernia due to the anterior approach of the procedure.Another patient experienced post-operative delirium.Finally, two patients experienced delayed onset of radiculopathy, which resolved with a short course of methylprednisolone.

• 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: 17558666
• MDR Text Key: 321274788
• Report Number: 3005075696-2023-00044
• Device Sequence Number: 1
• Product Code: OLO
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 61 YR
• Patient Sex: Male