BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM OLECRANON THREADED COMPRESSION ROD

    MDR report key: 2102853 · Received May 25, 2011

    Report

    Report Number
    3025141-2011-00011
    Event Type
    Injury
    Date Received
    May 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ACUMED LLC
    Product Code
    HSB
    PMA / PMN Number
    K071944
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: RETURNED DEVICE WAS VISUALLY AND FUNCTIONALLY INSPECTED AND ALL PARTS WERE FOUND TO BE WITHIN SPECIFICATIONS. NO OTHER RESULTS COULD BE DETERMINED FROM EVALUATION. RELATED MDRS: 3025141-2011-00016, 3025141-2011-00017.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED THAT AN ACUMED 4.5MM OLECRANON THREADED COMPRESSION ROD, PART NUMBER 40-0001-S, BACKED OUT OF THE PATIENT'S BONE. THE OLECRANON ROD WAS REMOVED AND AN UNKNOWN PLATE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM OLECRANON THREADED COMPRESSION ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ACUMED LLC 40-0001-S 233830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention