BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREW, LARGE SET

    MDR report key: 16693846 · Received April 6, 2023

    Report

    Report Number
    3006460162-2023-00008
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    June 6, 2022
    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

    THREE SET SCREWS CAME LOOSE ON RIGHT SIDE, ONE ON LEFT SIDE, ALL IN LUMBAR REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868856 SET SCREW, LARGE SET SET SCREW NKB ORTHOPEDIATRICS, CORP 00-1003-4001

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Hospitalization