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

Model Number TPL0059

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

Patient Problems Pain (1994); Impaired Healing (2378)

Event Date 11/20/2023

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 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.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

Zhao, w., wang, y., zhang, h., guo, j., han, j., lin, a., zhou, c., <(>&<)> ma, x.(2023).Analysis of the screw accuracy and postoperative efficacy of screw placement in single position and bipedal position in robot-assisted oblique lumbar interbody fusion: preliminary results of mazor x stealth usage.Orthopaedic surgery.Https://doi.Org/10.1111/os.13972.Objective: traditional manual olif combined with pedicle screw implantation has many problems of manual percutaneous screw implantat ion, such as high difficulty of screw placement, many fluoroscopies, long operation time, and many adjustments, resulting in greater trauma.The robot can perform various types of screw placement in the lateral recumbent position, which allows olif combined with p osterior screw placement surgery to be completed in a single position.To compare the screw accuracy and initial postoperative results of oblique anterior lumbar fusion with robot assisted screw placement in the lateral position and screw placement in the prone po sition for the treatment of lumbar spondylolisthesis.Methods: from may to june 2022, 45 patients with single-segment lumbar spondylolisthesis underwent mazor x-assisted oblique lumbar fusion in one position and renaissance-assisted surgery in two different positions, and screw accuracy was assessed on computed tomography scans according to a modified gertzbein¿robbins classification.Patients were divided into a single position group and a bipedal position group (the lateral position for complete oblique lumbar fusion and then changed to the prone position for posterior screw placement), and the perioperative parameters, including operative time, number of fluoroscopies, and operative complications, were recorded separately.The results of the clinical indicators, such as the visual analog scale (vas) for back and leg pain and the oswestry disability index (odi) score, were obtained.Results: there were no significant differences in the patients¿ demographic data between the two groups.The single position group had a shorter operative time and fewer fluoroscopies than the bipedal position group; the single position group had a higher percentage of screw accuracy at the a level than the bipedal position group, but there was no statistically significant difference between the two groups at the acceptable level (a + b) (p > 0.05).The single position group had better outcomes at the 1-week postoperative follow-up back pain vas scores (p <(><<)> 0.05).There was no statistically significant difference in the postoperative leg pain vas scores or the odi scores when compared to the control group.Conclusion: robot-assisted lateral position oblique lumbar interbody fusion with pedicle screw placement has the same accuracy as prone positioning.Single position surgery can significantly shorten the operation time and reduce the fluoroscopy.There was no significant difference in the long-term efficacy between the two groups.Reported events forty five patients underwent an olif, fifteen via single position and thirty five via bipedal position, to address degenerative lumbar spondylolisthesis.It was reported that among either position group there was myofascial pain and delayed would healing.These were not screw related complications.It was noted that in the single position group there was one case of postoperative myofascial pain, but the symptoms were improved significantly after conservative treatment.

• Brand Name: MAZOR X SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): VISIONSENSE LTD.; 20 hamagshimim st; petach-tikva ; IS
• Manufacturer (Section G): VISIONSENSE LTD.; 20 hamagshimim st; petach-tikva ; IS
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18685393
• MDR Text Key: 335198199
• Report Number: 9616637-2024-00002
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K182077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

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?: 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: 02/02/2024
• Initial Date FDA Received: 02/12/2024
• 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: 59 YR
• Patient Sex: Female