BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X SYSTEM

    MDR report key: 13001307 · Received December 14, 2021

    Report

    Report Number
    3005075696-2021-00133
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    July 1, 2021
    Report Date
    December 14, 2021
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    PMA / PMN Number
    K182077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    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: DIAZ-AGUILAR L, SHAH V, HIMSTEAD A, BROWN N, ABRAHAM M, PHAM M. SIMULTANEOUS ROBOTIC SINGLE-POSITION SURGERY (SR-SPS) WITH OBLIQUE L UMBAR INTERBODY FUSION: A CASE SERIES. WORLD NEUROSURGERY. 2021. 151: E1036-E1043. HTTPS://DOI.ORG/10.1016/J.WNEU.2021.05.043. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ABSTRACT: THE OBLIQUE LATERAL INTERBODY FUSION (OLIF) PROCEDURE IS AN IMPORTANT COMPONENT OF THE SURGEON¿S ARMAMENTARIUM FOR THE TREATMENT OF DEGENERATIVE SPINAL CONDITIONS. OLIF WITH POSTERIOR SPINAL FIXATION FREQUENTLY IS PERFORMED AND REQUIRES ADDITIONAL TIME BECAUSE THE PATIENT IS FLIPPED TO A PRONE POSITION AND RE-DRAPED. WE REPORT A SERIES OF CASES IN WHICH ROBOTIC ASSISTANCE WAS USED FOR A 2-SURGEON WORKFLOW IN WHICH OLIF AND SINGLE LATERAL POSITION POSTERIOR SPINAL FIXATION WERE PERFORMED AT THE SAME TIME, TERMED SIMULTANEOUS ROBOTIC SINGLE POSITION SURGERY (SR-SPS). DATA WERE COLLECTED RETROSPECTIVELY FROM MEDICAL RECORDS OF 13 CONSECUTIVE PATIENTS WHO UNDERWENT SR-SPS BY A SINGLE SURGEON AT AN ACADEMIC CENTER BETWEEN JUNE AND DECEMBER 2020. INSTRUMENTATION ACCURACY, TOTAL OPERATING ROOM TIME, ESTIMATED BLOOD LOSS, LENGTH OF STAY, AND COMPLICATIONS WERE ASSESSED. A TOTAL OF 13 PATIENTS WHOSE MEAN AGE WAS 64.1 YEARS (RANGE 46 - 84 YEARS) UNDERWENT SR-SPS OVER A 6-MONTH PERIOD. AVERAGE FOLLOW-UP WAS 10.3 MONTHS. ALL PATIENTS WERE TREATED FOR DEGENERATIVE SPINE DISEASE. THE AVERAGE OPERATIVE DURATION WAS 111.2 +- 25.2 MINUTES. A TOTAL OF 60 PEDICLE SCREWS WERE PLACED BILATERALLY IN THE LATERAL POSITION WITH AN ACCURACY RATE OF 95.0%. COMPLICATIONS INCLUDED 1 POSTOPERATIVE SEROMA, AND 1 PATIENT REQUIRED REOPERATION 3 MONTHS POSTOPERATIVELY DUE TO A FALL. WE REPORT THE FIRST CASE SERIES DESCRIBING SR-SPS. OUR STUDY SHOWS THAT THIS METHOD CAN REDUCE OPERATIVE TIME WHILE ENSURING ACCURATE. REPORTED EVENTS 1. DURING USE OF THE GUIDANCE SYSTEM FOR SPINAL SURGERY TO PLACE SCREWS, THERE WERE THREE LATERAL BREACHES AND NO MEDIAL OR INFERIOR BREACHES. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904337 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown