BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIATRICS BLADE PLATE

    MDR report key: 3856194 · Received April 25, 2014

    Report

    Report Number
    3006460162-2014-00003
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    ORTHOPEDIATRICS CORP
    Product Code
    HRS
    PMA / PMN Number
    K110959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SURGEON DISCOVERED THAT BLADE PLATE HAD FRACTURED AT TIME OF SCHEDULED REMOVAL AFTER HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252077 ORTHOPEDIATRICS BLADE PLATE BONE PLATE HRS ORTHOPEDIATRICS CORP NA M34715

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK