BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYSPINE S2-SI LEFT GUIDE

    MDR report key: 16876675 · Received May 5, 2023

    Report

    Report Number
    3005180920-2023-00378
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    March 31, 2023
    Report Date
    June 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    QSR
    PMA / PMN Number
    K220888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MYSPINE PROJECT MANAGER ANALYSIS: OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. WE ALSO REPRINTED THE GUIDES AND BONE MODEL IN ORDER TO CHECK THE FITTING AGAIN; THE RESULT IS CONFORM WITHOUT ANY KIND OF DOUBT.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MYSOLUTION DEPARTMENT: WE CHECKED ALL THE GUIDES DESIGNED FOR THE SACRUM (S01, S02-SI LEFT AND RIGHT). THE RESULT OF THE FITTING AND THE FUNCTIONAL CHECK IS CONFORM, THE GUIDES ARE GOOD AND STABLE WITHOUT ANY PROBLEM.

    Description of Event or Problem · 0

    AFTER THE SURGEON HAD DRILLED THE PILOT HOLES, AND PLACED THE SCREWS, IT WAS OBSERVED THAT THE LAST 4 SCREWS WERE INACCURATE WITH THE MYSPINE GUIDES. TO COMPLETE THE CASE, THE SURGEON USED A THORACIC PROBE AND MANIPULATED THE TRAJECTORY, TOOK X-RAYS, PUT A GUIDEWIRE DOWN, AND WENT THROUGH THE PROCESS OF PLACING THE SCREWS. THERE WAS A 30-MINUTESOF DELAY ON A SURGERY OF 3 HOURS AND THE SURGERY WAS COMPLETED SUCCESSFULLY, BUT ADDITIONAL ANESTHESIA WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574570 MYSPINE S2-SI LEFT GUIDE SPINE CUSTOM MADE GUIDE QSR MEDACTA INTERNATIONAL SA 09447S

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other