BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS MOBILE LEG POSITIONER

    MDR report key: 3716276 · Received March 6, 2014

    Report

    Report Number
    3005180920-2014-00024
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    FWX
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DOCUMENT REVIEW OF THE LOT INVOLVED (1111566 - SN (B)(4)) NO ANOMALIES WERE FOUND. THE FAILURE MODE IS UNLIKELY TO CAUSE PT HARM, EVEN IF IT CAN LEAD TO ADDITIONAL STEPS TO FIX THE PROBLEM.

    Description of Event or Problem · 1

    REFERENCE IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136942 AMIS MOBILE LEG POSITIONER LEG POSITIONER FOR HIP IMPLANTATION FWX MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1