MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR X STEALTH EDITION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number TPL0059

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

Patient Problems Fever (1858); Seroma (2069); Post Operative Wound Infection (2446); Fluid Discharge (2686)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

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: gonzalez d, ghessese s, cook d, hedequist d.Initial intraoperative experience with robotic-assisted pedicle screw placement with stealth navigation in pediatric spine deformity: an evaluation of the first 40 cases.Journal of robotic surgery.2020.Https://doi.Or g/10.1007/s11701-020-01159-3.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: pedicle screw fixation in pediatric spine surgery has become common practice given the fixation stability and improved curve correction.However, due to proximity to vital structures, accuracy is paramount.Literature has reported accuracy rates from 87.5 to 90% using traditional freehand techniques.This study presents our initial experience with pedicle screw placement using the newest generation of spinal robotics for treatment of pediatric spinal deformity.A cohort of patients, aged 8¿21 years, undergoing spinal fusion surgery using robotic-assisted technology was reviewed.Diagnoses, cobb angles, surgical time, robot time, number of screws placed, and complications were recorded.Accuracy of screw placement was assessed based on analysis of successful screw execution, evaluation screw position using intraoperative fluoroscopy and post-operative radiographs, and clinical evaluation.The average age was 14.5 years.Prevalent diagnoses included idiopathic (65%) and neuromuscular scoliosis (13%).Mean preoperative curve measured 66.8°.The median time for operation was 235 minutes with medians of 8 levels fused and 5 screws placed per patient.Of the 314 screws placed, we recorded a 98.7% accuracy rate.Lateral deviation was the most common cause of malpositioning.Post-operative plain films revealed no grossly misplaced screws.There were no perioperative neurologic deficits or malpositioned screws requiring reoperation.This is the first reported series of navigated spinal robotics used for pedicle screw placement in children.Our clinical success rate was 98.7% and there were no clinically relevant screw related complications.The study shows promising initial results of combined robotic-navigation techniques in pediatric patients.Reported events: one patient experience wound drainage and fever postoperatively from superficial wound infections.The patient was taken back to the operating room for exploration and debridement.There were no further complications.One patient experience wound drainage and fever postoperatively from superficial wound infections.The patient was taken back to the operating room for exploration and debridement.Fluid collections were seen subcutaneously which extended to the implants in one patient.There were no further complications.

• Brand Name: MAZOR X STEALTH EDITION
• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10935340
• MDR Text Key: 219348185
• Report Number: 3005075696-2020-00139
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109183213
• UDI-Public: 07290109183213
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2020

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: 11/06/2020
• Initial Date FDA Received: 12/02/2020
• Date Device Manufactured: 04/01/2019
• 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