BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LRG. HUDSON TO 1/4 SQ. ADAPTER

    MDR report key: 12454476 · Received September 10, 2021

    Report

    Report Number
    3006460162-2021-00037
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POWER ADAPTER WAS WOBBLY WHEN PLACE ON THE POWER AND DID NOT PROVIDE A COLINEAR SCREW INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354975 LRG. HUDSON TO 1/4 SQ. ADAPTER LRG. HUDSON ADAPTER NKB ORTHOPEDIATRICS, CORP 01-1003-5102

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR