BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT

    MDR report key: 11976202 · Received June 10, 2021

    Report

    Report Number
    3006460162-2021-00017
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    GFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS WE STARTED DRILLING FOR THE HOLES, THE 2.5 DRILL BIT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877245 2.5MM DRILL BIT DRILL BIT GFG ORTHOPEDIATRICS, CORP 01-1050-0002

    Patients

    Seq Age Sex Outcome Treatment
    1