BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIATRICS PROXIMAL FEMUR PLATE SYSTEM

    MDR report key: 3908715 · Received May 5, 2014

    Report

    Report Number
    3006460162-2014-00005
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    December 16, 2011
    Manufacturer
    ORTHOPEDIATRICS CORP
    Product Code
    HRS
    PMA / PMN Number
    K111086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BONE PLATE BROKE MIDPOINT DIRECTLY IN THE MIDDLE OF A SCREW HOLE. DID NOT USE LOCKING SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269455 ORTHOPEDIATRICS PROXIMAL FEMUR PLATE SYSTEM BONE PLATE HRS ORTHOPEDIATRICS CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK