BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0 MM DRILL BIT

    MDR report key: 12084612 · Received June 29, 2021

    Report

    Report Number
    3006460162-2021-00023
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    GFG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGERY THE DRILL BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986444 2.0 MM DRILL BIT DRILL BIT GFG ORTHOPEDIATRICS, CORP 01-1005-0003 91300757

    Patients

    Seq Age Sex Outcome Treatment
    1