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 Pain (1994); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Date 01/30/2024

Event Type  Injury  

Event Description

Nagata, k., gum, j.L., brown, m., daniels, c., hines, b., carreon, l.Y., glassman, s.D.(2024).Risk factors for medial breach during robotic-assisted cortical bone trajectory screw insertion.World neurosurgery, 184.Https://doi.Org/10.1016/j.Wneu.2024.01.168 objective: we describe the incidence of, and identify the risk factors for, a medial breach of the pedicle wall during robotic-assisted cortical bone trajectory (ra-cbt) screw insertion.Method: we analyzed a consecutive series of adult patients who underwent ra-cbt screw placement from january 2019 to july 2022.To assess the pedicle wall medial breach, postoperative computed tomography (ct) images were analyzed.Patient demographic data and screw data were compared between patients with and without a medial breach.The hounsfield units (hus) on the l1 midvertebral axial ct scan was used to evaluate bone quality.Result: of 784 cbt screws in 145 patients, 30 (3.8%) had a medial breach in 23 patients (15.9%).One screw was grade 2, and the others were grade 1.Patients with a medial breach had a lower hu value compared with the patients without a medial breach (123.3 vs.150.5; p [0.027).A medial breach was more common in the right than left side (5.5% vs.2.0%; p [ 0.014).More than one half of the screws with a medial breach were found in the upper instrumented vertebra (uiv) compared with the middle construct or lowest instrumented vertebra (6.7% vs.1.3% vs.2.7%; p [ 0.003).Binary logistic regression showed that low hu values, right-sided screw placement, and uiv were associated with a medial breach.No patients returned to the operating room for screw malposition.No differences were found in the clinical outcomes between patients with and without a medial breach.Conclusion: the incidence of pedicle wall medial breach was 3.8% of ra-cbt screws in the postoperative ct images.A low hu value measured in the l1 axial image, right-sided screw placement, and uiv were associated with an increased risk of medial breach for ra-cbt screw placement.Reported event one hundred and forty five patients underwent lumbar spine fusion surgery for degenerative conditions.The study define a grade one breach as more than half the screw diameter passed through the pedicle cortex, and grade two was a screw that totally passes the cortex.Of the one hundred and forty five patients to was found that there were thirty medial breaches, one was grade two and twenty nine were grade one, and ten lateral breaches, two grade twos and eight grade ones.Along with these there were fifteen anterior breaches, six end plate breaches, and six foramen breaches.Fourteen screws were removed and not replaced, seven were shifted screws and sever were skived.Of patients with medial breaches only one patient experienced a surgical site infection.Of patients that did not experience a medial breach, twelve patients had revisions, two patients had a cell saver used, four patients experienced a dural tear, twelve patients revisited the emergency department for pain, and seven had surgical site infections.

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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19098311
• MDR Text Key: 340103594
• Report Number: 3005075696-2024-00047
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

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?: Yes
• 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: 04/10/2024
• Initial Date FDA Received: 04/12/2024
• 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): Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male