BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORZA IMPLANT INSERTER

    MDR report key: 6183413 · Received December 16, 2016

    Report

    Report Number
    2183449-2016-00025
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 10, 2016
    Report Date
    February 9, 2017
    Manufacturer
    ORTHOFIX INC
    Product Code
    MDM
    PMA / PMN Number
    K103111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT DURING THE SURGERY THE SURGEON WENT TO INSERT THE IMPLANT AND THE PRONGS BROKE OFF OF THE INSERTERS. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PRONGS WHICH RESULTED IN A DELAY IN THE SURGERY.

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT DURING THE SURGERY THE SURGEON WENT TO INSERT THE IMPLANT AND THE PRONGS BROKE OFF OF THE INSERTERS. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PRONGS WHICH RESULTED IN A DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834084 FORZA IMPLANT INSERTER 9MM STRAIGHT IMPLANT INSERTER MDM ORTHOFIX INC 89-0102 (2) 34295-NH22 (2)

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other