BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 OLECRANON THREADED COMPRESSION ROD

    MDR report key: 1863862 · Received October 11, 2010

    Report

    Report Number
    3025141-2010-00036
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 6, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ACUMED LLC
    Product Code
    HSB
    PMA / PMN Number
    K071944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY ONE WEEK POST PLACEMENT OF AN ACUMED 4.5 OLECRANON THREADED COMPRESSION ROD, POST OPERATION X-RAYS SHOW THAT THE OLECRANON ROD HAS STARTED TO BACK OUT OF THE BONE AND PUSHING ON THE PATIENT'S SKIN. THE ROD IS STILL IMPLANTED IN THE PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5 OLECRANON THREADED COMPRESSION ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ACUMED LLC 40-0001-S

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR