BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5414171 · Received February 5, 2016

    Report

    Report Number
    3025141-2016-00034
    Event Type
    Injury
    Date Received
    February 5, 2016
    Report Date
    January 20, 2016
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K102998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A FLEXOR TENDON RUPTURE OCCURRED FOLLOWING IMPLANTATION OF AN ACULOC DISTAL RADIUS PLATE; EXPLANTATION WAS PERFORMED. REPORTED IN THE JOURNAL OF BONE AND JOINT SURGERY (2011; 93:328-35).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72129 PLATE, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention