BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAKO ROBOT INTEGRATED CUTTING SYSTEM

    MDR report key: 11648171 · Received April 9, 2021

    Report

    Report Number
    MW5100697
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 8, 2021
    Manufacturer
    MAKO SURGICAL CORPORATION
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE MAKO INTEGRATED CUTTING SYSTEM MICS SECUREMENT TAB AND PIN FELL OFF OF DEVICE DURING PROCEDURE. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542242 MAKO ROBOT INTEGRATED CUTTING SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORPORATION 209063 42060319

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR