BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    800004 - ACCULIF INSERTION HANDLE

    MDR report key: 3170614 · Received April 17, 2013

    Report

    Report Number
    3008172843-2013-00001
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 17, 2013
    Manufacturer
    COALIGN INNOVATIONS INC.
    Product Code
    MAX
    PMA / PMN Number
    K123752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND INSPECTION. IT WAS CONFIRMED THAT THE TIP OF THE INSTRUMENT WAS BROKEN AND ABSENT. IT IS LIKELY THAT THIS DAMAGE OCCURRED DURING CLEANING AND STERILIZATION PRIOR TO USE. THIS IS A REUSABLE INSTRUMENT THAT IS CLEANED AND STERILIZED BY THE HOSPITAL BEFORE EACH USE. A REPLACEMENT DEVICE WAS PROVIDED TO THE USER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT A USER WAS UNABLE TO CONNECT THE IMPLANT TO THE INSERTION HANDLE ("INSTRUMENT"). THE DISTRIBUTOR REPRESENTATIVE REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN. ANOTHER INSTRUMENT WAS PROVIDED TO THE USER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167009 800004 - ACCULIF INSERTION HANDLE ACCULIF INSERTION HANDLE MAX COALIGN INNOVATIONS INC. 7044-01 01221301

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other