BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL LOCKING PLATE

    MDR report key: 3003843 · Received March 12, 2013

    Report

    Report Number
    9610905-2013-00003
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    October 27, 2012
    Report Date
    February 25, 2013
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH CO. KG
    Product Code
    HRS
    PMA / PMN Number
    K032413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVISIONAL SURGERY WAS PERFORMED DUE TO STERNAL COMPLICATION, POSSIBLE INFECTION. DURING SURGERY, SURGEON DISCOVERED A STERNAL PLATE HAD BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103351 STERNAL LOCKING PLATE HRS KARL LEIBINGER MEDIZINTECHNIK GMBH CO. KG 24-025-01 31625157

    Patients

    Seq Age Sex Outcome Treatment
    1 Other