BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO SURGICAL CORP

    MDR report key: 3807222 · Received May 8, 2014

    Report

    Report Number
    MW5036066
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    December 9, 2013
    Report Date
    April 21, 2014
    Manufacturer
    MAKO SURGICAL CORP
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING SURGICAL LEFT THR WITH MAKOPLASTY. PROCEDURE WAS COMPLICATED BY INTRAOPERATIVE DISPLACEMENT OF THE ACETABULAR DEFECT POINT WITHIN THE BONY PELVIS. TEAM WAS UNABLE TO REMOVE THE MARKER FROM THE PELVIS VIA THE OPEN THR SITE. THUS THR WAS COMPLETED AND GENERAL SURGERY WAS CALLED INTO OPERATING ROOM TO MAKE AN ABDOMINAL INCISION TO REMOVE MARKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279645 MAKO SURGICAL CORP ACETABULAR DEFECT POINT JDI MAKO SURGICAL CORP 140010-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R