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 Bruise/Contusion (1754); Pain (1994); Spinal Column Injury (2081); Post Operative Wound Infection (2446); Bowel Perforation (2668); Unspecified Nervous System Problem (4426)

Event Date 09/06/2023

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.B.5.Included 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.

Event Description

Tomoyuki asada , chad z.Simon , amy z lu , samuel adida , marcel dupont , philip m parel , joshua zhang , satyaj bhargava , kyle w.Morse , james e.Dowdell , sravisht iyer , sheeraz a qureshi , robot-navigated pedicle screw insertion can reduce intraoperative blood loss and length of hospital stay: analysis of 1,633 patients utilizing propensity score matching, the spine journal (2023), doi: https://doi.Org/10.1016/j.Spinee.2023.09.004 background context: navigation and robotic technologies have emerged as an alternative option to conventional freehand techniques for pedicle screw insertion.However, the effectiveness of these technologies in reducing the perioperative complications of spinal fusion surgery remains limited due to the small cohort size in the existing literature.Purpose: to investigate whether utilization of robotically navigated pedicle screw insertion can reduce the perioperative complications of spinal fusion surgery¿including reoperations¿with a sizeable cohort.Study design: retrospective study.Patient sample: patients who underwent primary lumbar fusion surgery between 2019 and 2022.Outcome measures: perioperative complications including readmission, reoperation, its reasons, estimated blood loss, operative time, and length of hospital stay methods: patients¿ data were collected including age, sex, race, body mass index (bmi), upper instrumented vertebra (uiv), lower-instrumented vertebra (liv), number of screws inserted, and primary procedure name.Patients were classified into the following two groups: freehand group and robot group.The variable-ratio greedy matching was utilized to create the matched cohorts by propensity score and compared the outcomes between the two group.Results: a total of 1,633 patients who underwent primary instrumented spinal lumbar fusion surgery were initially identified (freehand 1,286; robot 347).After variable ratio matching was performed with age, sex, bmi, fused levels, and upper instrumented vertebrae level, 694 patients in the freehand group and 347 patients in robot groupswere selected.The robot group showed less ebl (418.9 ± 398.9 vs.199.2 ± 239.6 ml; p=0.001), shorter los (4.1 ± 3.1 vs.3.2 ± 3.0 days; p=0.001) and similar operative time (212.5 vs.222.0 min; p=0.151).Otherwise, there was no significant difference in readmission rate (3.6% vs.2.6%; p=0.498), reoperation rate (3.2 % vs.2.6 %; p=0.498), and screw malposition requiring reoperation (5 cases, 0.7% vs 1 case, 0.3%; p=1.000).Conclusion: perioperative complications requiring readmission and reoperation were similar between fluoroscopy guided freehand and robotic surgery.Robot-guided pedicle screw insertion can enhance surgical efficiency by reducing intraoperative blood loss and length of hospital stay without extending operative time.Reported events three hundred forty seven patients underwent a lumbar spinal surgery.Several complications were overserved.One patient had to be readmitted due to postoperative ileus/perforation.Nine patients were re-operated on, as three had surgical site infections, two had a hematoma, and four patients had proximal/distal junctional kyphosis, drop foot, and/or neck pain.

• 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: 18046697
• MDR Text Key: 327050136
• Report Number: 3005075696-2023-00052
• 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: 11/01/2023

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: 10/20/2023
• Initial Date FDA Received: 11/01/2023
• 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): Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male