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U.S. Department of Health and Human Services

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

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MAZOR ROBOTICS LTD MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TPL0059
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/01/2021
Event Type  Injury  
Event Description
Abstract: accurate pedicle screw placement is critical to surgically correct pediatric high-grade spondylolisthesis (hgs). The recent advent of robotics coupled with computer-assisted navigation (ran) may represent a novel option to improve surgical outcomes of hgs, secondary to enhanced pedicle screw placement safety. This series presents the hgs-ran technique adopted by our site, describing its surgical outcomes and feasibility. Consecutive patients with a diagnosis of hgs (meyerding grade iii to v), operated on using ran from 2019 to 2020 at a single-center were reviewed. Demographics, screw accuracy, sagittal l5-s1 parameters, complications, and perioperative outcomes were described. All patients were treated with instrumentation, decompression, posterior lumbar interbody fusion, and reduction. Robotic time included anatomic registration to end of screw placement. Screw accuracy, defined as a screw placed safely within the planned intrapedicular trajectory was characterized by the gertzbein-robbins system for patients with additional 3-dimensional imaging. Ten hgs patients, with an average age of 13. 7 years old, were included in the series. All 62 screws were placed without neurological deficit or complication. Seven patients had additional 3-dimensional imaging to assess screw accuracy (42 of 62 screws). One hundred percent of screws were placed safely with no pedicle breaches (gertzbein-robbins¿grade a). Thirty screws (48%) were placed through separate incisions that were percutaneous/transmuscular and 32 screws (52%) were inserted through the main incision. There were statistically significant improvements in l5 slippage (p
=
0. 002) and lumbosacral angle (p
=
0. 002), reflecting successful hgs correction. The total median operative time was 324 minutes with the robotic usage time consuming a median of 72 minutes. Median estimated blood loss was 150 ml, and length-of-stay was a median 3 days. This case-series demonstrates that ran represents a viable op tion for hgs repair, indicated by high screw placement accuracy, safety, and l5-s1 slippage correction. Surgeons looking to adopt an emerging technique to enhance safety and correction of pediatric hgs should consider the ran platform. Reported events: after use of the guidance system for spinal surgery to place screws, one patient experienced a postoperative infection requiring return to the operating room for irrigation and debridement.
 
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: linden g, birch c, hresko t, cook d, hedequist d. Intraoperative use of robotics with navigation for pedicle screw placement in treatment of pediatric high-grade spondylolisthesis: a preliminary report. Journal of pediatric orthopedics. 2021. 41 (10). Doi: 10. 1097/bpo. 0000000000001947. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMAZOR X SYSTEM
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13002814
MDR Text Key285169596
Report Number3005075696-2021-00134
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 Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
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
Date Manufacturer Received11/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2019
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: 12/14/2021 Patient Sequence Number: 1
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