BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X SYSTEM

    MDR report key: 13002814 · Received December 14, 2021

    Report

    Report Number
    3005075696-2021-00134
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 1, 2021
    Report Date
    December 14, 2021
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109183213
    PMA / PMN Number
    K182077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890303 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109183213

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention