BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6770372

    MDR report key: 6770372 · Received August 7, 2017

    Report

    Report Number
    6770372
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    May 23, 2017
    Report Date
    July 28, 2017
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN DRIVING THE CAGE PROSTHESIS INTO PLACE A SMALL PIECE SPLINTERED OFF. ALL PIECES WERE PLACED ON THE MAYO STAND BUT THE FRAGMENT WAS LATER LOST. THE IMPLANT AREA WAS THOROUGHLY IRRIGATED WITH SALINE PRIOR TO CONTINUING SURGERY. THE IMPLANT ONLY HAS A SMALL X-RAY MARKER IN THE BODY AND THE FRAGMENT WOULD NOT BE VISIBLE ON X-RAY HOWEVER AN INTRA-OP CAT SCAN WAS PERFORMED AS PART OF THE PROCEDURE.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR