BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X SYSTEM

    MDR report key: 13003542 · Received December 14, 2021

    Report

    Report Number
    3005075696-2021-00135
    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
    UDI-DI
    07290109181158
    PMA / PMN Number
    K182077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: 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: KATSEVMAN G, SPENCER R, DAFFNER S, BHATIA S, MARSH R, FRANCE J, CUI S, DEKESEREDY P, SEDNEY C. ROBOTIC-NAVIGATED PERCUTANEOUS PEDICLE SCREW PLACEMENT HAS LESS FACET JOINT VIOLATION THAN FLUOROSCOPY-GUIDED PERCUTANEOUS SCREWS. WORLD NEUROSURGERY. 2021. E1-E7. HTTPS ://DOI.ORG/10.1016/J.WNEU.2021.04.117. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ABSTRACT: TO DIRECTLY COMPARE ROBOTIC-VERSUS FLUOROSCOPY-GUIDED PERCUTANEOUS PEDICLE SCREW (PPS) PLACEMENT IN THORACOLUMBAR SPINE TRAUMA WITH A FOCUS ON CLINICALLY ACCEPTABLE PEDICLE SCREW ACCURACY AND FACET JOINT VIOLATION (FJV). A RETROSPECTIVE CHART REVIEW ASSESSED 37 TRAUMA PATIENTS UNDERGOING PERCUTANEOUS THORACIC AND/OR LUMBAR FIXATION. POSTOPERATIVE COMPUTED TOMOGRAPHY IMAGES WERE REVIEWED BY AUTHORS BLINDED TO SURGICAL TECHNIQUE WHO ASSESSED PEDICLE SCREW TRAJECTORY ACCURACY AND FJV FREQUENCY. SEVENTEEN PATIENTS UNDERWENT PLACEMENT OF 143 PPS WITH ROBOTIC ASSISTANCE (ROBOT GROUP), COMPARED WITH 20 PATIENTS RECEIVING 149 PPS USING FLUOROSCOPY ASSISTANCE (CONTROL GROUP). OVERALL, THE ROBOT COHORT DEMONSTRATED DECREASED FJV FREQUENCY OF 2.8% VERSUS 14.8% IN CONTROLS (P = 0.0003). WHEN FURTHER STRATIFIED BY LEVEL OF SURGERY (I.E. UPPER THORACIC, LOWER THORACIC, LUMBAR SPINE), THE ROBOT GROUP HAD FJV FREQUENCIES OF 0%, 3.2%, AND 3.7%, RESPECTIVELY, COMPARED WITH 17.7% (P = 0.0209), 14.3% (P = 0.0455), AND 11.9% (P = 0.2340) IN CONTROLS. THE ROBOT GROUP HAD 84.6% CLINICALLY ACCEPTABLE SCREW TRAJECTORIES COMPARED WITH 81.9% IN CONTROLS (P = 0.6388). WITHIN THE UPPER THORACIC, LOWER THORACIC, AND LUMBAR REGIONS, THE ROBOT GROUP HAD ACCEPTABLE SCREW TRAJECTORIES OF 66.7%, 87.1%, AND 90.7%, RESPECTIVELY, COMPARED WITH 58.8% (P = 0.6261), 91.1% (P = 0.5655), AND 97.6% (P = 0.2263) IN CONTROLS. THERE WAS NO SIGNIFICANT DIFFERENCE IN CLINICALLY ACCEPTABLE SCREW TRAJECTORY ACCURACY BETWEEN ROBOTIC VERSUS FLUOROSCOPY-GUIDED PPS PLACEMENT. HOWEVER, THE ROBOT COHORT DEMONSTRATED A STATISTICALLY SIGNIFICANTLY DECREASED FJV OVERALL AND SPECIFICALLY WITHIN THE THORACIC SPINE REGION. USE OF ROBOTIC TECHNOLOGY MAY IMPROVE RADIOGRAPHIC OUTCOMES FOR A SUBSET OF PATIENTS OR SPINE SURGERIES. REPORTED EVENTS 1. DURING USE OF THE GUIDANCE SYSTEM FOR SPINAL SURGERY TO PLACE 143 SCREWS IN 17 PATIENTS, 44 SCREWS WERE DEVIATED LESS THAN 2 MM, 17 SCREWS WERE DEVIATED BETWEEN 2-4 MM, AND 5 SCREWS WERE DEVIATED BETWEEN 4-6 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895087 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109181158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown