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 Problem Unspecified Infection (1930)

Event Date 10/01/2021

Event Type  Injury  

Event Description

Abstract: multiple-rod constructs (mrcs) are often used in deformity correction for increased stability and rigidity.There are currently no reports showing minimally invasive placement of mrcs in adult deformity surgery and its technical feasibility through preoperative software planning.Data were collected retrospectively from medical records of six consecutive patients who underwent minimally invasive mrcs with robotics planning by a single surgeon at an academic center between march¿august 2020.A total of six patients (4 females, mean age 69.7 years) underwent minimally invasive long-segment (6 +) posterior fixation with multiple rods (3 +) using the mazor x stealth edition robotics platform.Average follow-up was 14.3 months.All patients underwent oblique lumbar interbody fusion (olif) as a first stage, followed by second stage posterior fixation in the same day.The mean number of levels posteriorly instrumented was 8.8.One patient underwent 3 rod fixation (1 iliac, 2 s2ai) and 5 patients underwent quad rod fixation (2 iliac, 2 s2ai).The mean time to secure all rods was 8 min 36 s.Mean improvement in spinopelvic parameters was -4.9 cm sagittal vertical axis, 18.0° lum bar lordosis, and -10.7° pelvic tilt with an average pelvic incidence of 62.5°.Estimated blood loss (ebl) was 100¿250 cc with no blood transfusions, and all but one patient ambulated on postoperative day 1 or 2.Spinal robotics brings us into a new era of minimally invasive construct design.To our knowledge, this is the first description of the technical feasibility of mrcs in minimally invasive adult spinal deformity surgery.Reported events 1.After use of the guidance system for spinal surgery to place screws, one patient required a revision for a wound infection related to the olif approach.

Manufacturer Narrative

Date of event: please note that this date is based off the date of publication of the article as the actual event date was not provided.The reported event was from the following literature article: pham m, shah v, diaz-aguilar l, osorio j, lehman r.Minimally invasive multiple-rod constructs with robotics planning in adult spinal deformity surgery: a case series.European spine journal.2021.Https://doi.Org/10.1007/s00586-021-06980-4.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; 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: 13003869
• MDR Text Key: 286868172
• Report Number: 3005075696-2021-00137
• 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: 12/14/2021

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: 11/27/2021
• Initial Date FDA Received: 12/14/2021
• 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
• Patient Age: 66 YR
• Patient Sex: Male