BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMCP

    MDR report key: 8161956 · Received December 13, 2018

    Report

    Report Number
    3007289093-2018-00033
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 7, 2018
    Report Date
    December 13, 2018
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE XMCP REAMER BEGAN TO TWIST AND BREAK AT THE DISTAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998318 XMCP REAMER HTO EXTREMITY MEDICAL, LLC. 3327501

    Patients

    Seq Age Sex Outcome Treatment
    1