BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMIS LEG POSITIONER

    MDR report key: 4586349 · Received March 6, 2015

    Report

    Report Number
    3005180920-2015-00024
    Event Type
    Injury
    Date Received
    March 6, 2015
    Report Date
    October 14, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LXH
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE CANNOT HAVE DATA ABOUT CODE AND LOT OF THE AMIS TABLE, AS PER THE COMMUNICATION RECEIVED FROM OUR BRANCH IN THE USA ON (B)(6) 2015: "THE SURGERY TOOK PLACE OVER A YEAR AGO. WE CANNOT DEFINITIVELY SAY WHICH TABLE WAS USED DURING THIS SURGERY." WE COLLECTED DIFFERENT OPINIONS ON THE CASE, BOTH INTERNALLY IN MEDACTA AND FROM AN EXPERT SURGEON AND THEY ARE ALL LISTED IN THE ATTACHMENT 1 TO THE MDR.

    Additional Manufacturer Narrative · 1

    ON 14 SEPTEMBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 12 OCTOBER 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156457 AMIS LEG POSITIONER SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1