BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMED® LKG MPJ PETITE PLATE 4 DEG, RIGHT

    MDR report key: 2715935 · Received August 27, 2012

    Report

    Report Number
    3025141-2012-00074
    Event Type
    Injury
    Date Received
    August 27, 2012
    Date of Event
    June 21, 2012
    Report Date
    July 30, 2012
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K033639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ACUMED LKG MPJ PETITE PLATE 4 DEG, RIGHT ((B)(4)) WAS IMPLANTED ON (B)(6) 2012. APPROXIMATELY 5 MONTHS LATER THE PLATE BROKE AND WAS EXPLANTED ON (B)(6) 2012. THE PATIENT STATED THERE WAS NO ADDITIONAL TRAUMA AND IT BROKE WHILE WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUMED® LKG MPJ PETITE PLATE 4 DEG, RIGHT BONE PLATE HWC ACUMED LLC 70-0330

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention