BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOBRIDGE PLATING SYSTEM

    MDR report key: 5916071 · Received August 30, 2016

    Report

    Report Number
    3005670412-2016-00012
    Event Type
    Injury
    Date Received
    August 30, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 25, 2016
    Manufacturer
    ACUTE INNOVATIONS, LLC
    Product Code
    HRS
    UDI-DI
    10814493010609
    PMA / PMN Number
    K120163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: 3005670412-2016-00011 - PLATE 1; 3005670412-2016-00013 - PLATE 3.

    Description of Event or Problem · 1

    EXPLANT OF BIOBRIDGE PLATES USED IN THE PECTUS REPAIR OF A PEDIATRIC PATIENT. THREE PLATES WERE IMPLANTED (B)(6) 2016. SURGEON KNEW IT WAS OFF-LABEL USE. THE PATIENT DEVELOPED PAINFUL DISCOMFORT DURING MOVEMENT WHICH LED TO REMOVAL OF THE THREE PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566553 BIOBRIDGE PLATING SYSTEM PLATE, FIXATION SYSTEM HRS ACUTE INNOVATIONS, LLC RRP1501 L1407008 10814493010609

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention