BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIATRICS PEDILOC BONE PLATE

    MDR report key: 2950542 · Received February 5, 2013

    Report

    Report Number
    3006460162-2013-00004
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ORTHOPEDIATRICS CORP
    Product Code
    HRS
    PMA / PMN Number
    K083286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BROKEN BONE PLATE. THE BROKEN PLATE IS A 3.5MM PLATE, REPLACED WITH A 4.5MM PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48049 ORTHOPEDIATRICS PEDILOC BONE PLATE BONE PLATE HRS ORTHOPEDIATRICS CORP NA 09O038

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other| R