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U.S. Department of Health and Human Services

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

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MAZOR ROBOTICS LTD MAZOR X STEALTH EDITION ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameMAZOR X STEALTH EDITION
Type of DeviceORTHOPEDIC 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 Key10935340
MDR Text Key219348185
Report Number3005075696-2020-00139
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTPL0059
Device Catalogue NumberTPL0059
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/02/2020 Patient Sequence Number: 1
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