BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREW, LARGE SET

    MDR report key: 16693892 · Received April 6, 2023

    Report

    Report Number
    3006460162-2023-00007
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    September 20, 2017
    Report Date
    April 6, 2023
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    NKB
    PMA / PMN Number
    K150600
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    SET SCREW CAME LOOSE PRODUCT WAS NOT RETURN AS IS HOSPITAL POLICY TO SCRAP AT LOCATION. DEVICE WAS IMPLANTED ON (B)(6) 2015 AND REMOVED ON (B)(6) 2016 WITH A SECOND REVISION SURGERY OCCURRING ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799458 SET SCREW, LARGE SET SET SCREW NKB ORTHOPEDIATRICS, CORP 00-1003-4001

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Hospitalization