BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL HUMERAL PLATE, EXTRA LONG, R.

    MDR report key: 4193618 · Received October 22, 2014

    Report

    Report Number
    3025141-2014-00248
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT:3025141-2014-00249: SCREW 1,3025141-2014-00250: SCREW 2,3025141-2014-00251: SCREW 3,3025141-2014-00252: SCREW 4,3025141-2014-00253: SCREW 5,3025141-2014-00254: SCREW 6.

    Description of Event or Problem · 1

    THE PATIENT BROKE THE HUMERUS AND WAS TREATED WITH A COMPETITOR'S HUMERUS PLATE. THE PATIENT EXPERIENCED NON-UNION AND THE COMPETITOR'S PLATE WAS EXPLANTED. THE FRACTURE WAS THEN TREATED WITH THE ACUMED PROXIMAL HUMERAL PLATE. APPROXIMATELY THREE WEEK AFTER IMPLANTATION, THE SCREWS AND PLATE LIFTED OFF THE BONE; TWO OF THE SCREWS WERE BROKEN. EXPLANTATION IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672565 PROXIMAL HUMERAL PLATE, EXTRA LONG, R. PLATE, FIXATION, BONE HRS ACUMED LLC PL-PHXGR

    Patients

    Seq Age Sex Outcome Treatment
    1