BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MIDAS REX BURR 4.5MM MATCH HEAD

    MDR report key: 12576517 · Received October 4, 2021

    Report

    Report Number
    MW5104386
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    September 16, 2021
    Report Date
    October 1, 2021
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC MIDAS REX BURR BROKE WHILE IN USE; COMPONENTS CONTAINED WITHIN PROPER ATTACHMENT. USE STOPPED IMMEDIATELY. ALL COMPONENTS REMOVED WITHOUT NEGATIVE IMPACT TO THE PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464355 MEDTRONIC MIDAS REX BURR 4.5MM MATCH HEAD BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC POWERED SURGICAL SOLUTIONS T12MH45D H5645620

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention