BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUTIE II

    MDR report key: 6170559 · Received December 13, 2016

    Report

    Report Number
    3005670412-2016-00014
    Event Type
    Injury
    Date Received
    December 13, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ACUTE INNOVATIONS, LLC
    Product Code
    JDQ
    UDI-DI
    10814493010753
    PMA / PMN Number
    K101170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLATE WAS REMOVED FROM PATIENT BECAUSE THE SURGEON APPARENTLY DID NOT CUT THE WIRE SHORT ENOUGH AND THE PATIENT WAS HAVING SOME DISCOMFORT. SAID THEY ALWAYS CUT THE WIRE AS SHORT AS THEY CAN BUT THIS PARTICULAR PATIENT WAS VERY THIN, SO THEY'RE THINKING THIS MAY HAVE PLAYED A PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823118 ACUTIE II CERCLAGE, FIXATION JDQ ACUTE INNOVATIONS, LLC ACUTIE II 10814493010753

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention