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 Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 11/02/2023

Event Type  Injury  

Event Description

Nagata k, glassman sd, brown me, daniels cl, schmidt go, carreon ly, hines b, gum jl.Risk factors of screw malposition in robot-assisted cortical bone trajectory: analysis of 1344 consecutive screws in 256 patients.Spine (phila pa 1976).2023 sep 28.Doi: 10.109 7/brs.0000000000004827.Epub ahead of print.Pmid: 37767783.Objective: to describe the incidence of and identify risk factors for intraoperative screw malposition secondary to skive or shift during robot-assisted cortical bone trajectory (racbt) insertion.Methods: a consecutive series of patients older than 18 years who underwent ra-cbt screw placement between january 2019 and july 2022 were enrolled.Baseline demographic and surgical data, hounsfield units (hu) at l1, and vertebral shape related to screw planning were collected.Skive or shift was recorded in the operating room on a data collection form.Results: of 1344 cbt screws in 256 patients, malposition was recognized intraoperatively in 33 screws (2.4%) in 27 patients (10.5%); 19 via skive in 17 and 14 via shift in 10 patients.These patients had higher bmi than patients without malposition (33.0 kg/m2 vs 30.5 kg/m2, p=0.037).Patients with skive had higher hu (178.2 vs 145.2, p=0.035), compared to patients with shift (139.2 vs 145.2, p=0.935) and patients without screwmalposition.More than half of screw malposition was observed at the uiv.At the uiv, if the screw¿s overlap to the bone surface at the insertion point was decreased, skive was more likely (57% vs 87%, p<(><<)> 0.001).No patients were returned to the operating room for screw revision.Conclusions: intraoperative screw malposition occurred in 2.4% of ra-cbt.High bmi was associated with screw malposition, regardless of etiology.Skive was associated with high hu and decreased screw overlap to bone surface at the insertion point.Reported event two hundred and fifty six patients underwent elective lumbar spine fusion surgery to address various spinal issues.Of these patients twenty seven patients experienced misplacement of thirty three screws.Nineteen screws skived, while fourteen screws were due to shifts.Twenty two were misplaced on the left and eleven were misplaced on the right.Four misplaced screws were at l2, five were at l3, fourteen were at l4, and ten were at l5.These procedures were delayed by eighteen minutes.Eleven screws were removed; seven malposition, four non-malposition.A high bmi was associated with both skive and shift, while high hu was associated with screw malposition with skive only.Upper instrumented vertebrae (uiv) analyses also determined that decreased planned screw overlap to the bone surface at entry point was associated with skive occurrence.In malposition screw procedures, there was one dural tear.In procedures were no malposition occurred it was noted that there were three blood transfusions, five cell savers used, and six dural tears.

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.

• 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: 18194603
• MDR Text Key: 328891310
• Report Number: 3005075696-2023-00056
• 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: 11/22/2023

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?: 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: 11/02/2023
• Initial Date FDA Received: 11/22/2023
• 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: 59 YR
• Patient Sex: Female