BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5/6.0 MINI REDUCER

    MDR report key: 11976145 · Received June 10, 2021

    Report

    Report Number
    3006460162-2021-00008
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BROKE WITH REDUCING ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877239 5.5/6.0 MINI REDUCER MINI REDUCER NKB ORTHOPEDIATRICS, CORP 01-1300-6000

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR