BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMMERLOCK 1.1

    MDR report key: 4780308 · Received May 15, 2015

    Report

    Report Number
    1649263-2015-00005
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    February 6, 2015
    Report Date
    May 15, 2015
    Manufacturer
    BIOMEDICAL ENT., INC.
    Product Code
    HTY
    PMA / PMN Number
    K131640
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INITIAL HAMMERTOE CORRECTION IMPLANTATION TOOK PLACE (B)(6) 2014 USING THREE HAMMERLOCKS SIZE SMALL. DURING FOLLOW UP VISIT ON (B)(6) 2015, IT WAS CONFIRMED THAT ONE OF THE THREE HAMMERLOCKS HAD BROKEN. REVISION SURGERY AND EXPLANT TOOK PLACE (B)(6) 2015. NO ADDITIONAL DETAILS PROVIDED. ALTHOUGH BME FIRST LEARNED OF REVISION SURGERY ON (B)(6) 2015, DESPITE NUMEROUS ATTEMPTS, COMPLAINT ALONG WITH DEVICE WAS NOT CONFIRMED UNTIL (B)(6) 2015. ADDITIONAL DETAILS WERE RECEIVED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320127 HAMMERLOCK 1.1 PIN, FIXATION, SMOOTH HTY BIOMEDICAL ENT., INC. HLXS BMEHL13500C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention