BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO PL/OL

    MDR report key: 3987476 · Received June 11, 2014

    Report

    Report Number
    3005032068-2014-00003
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 10, 2014
    Manufacturer
    AMEDICA CORP.
    Product Code
    MAX
    PMA / PMN Number
    K091278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXTRACTION INSTRUMENT WAS BEING USED TO FLIP THE DEVICE. IT WAS NOT INTENDED TO BE USED FOR THIS PURPOSE. THE EXTRACTION TOOL CROSS THREADED DURING INSERTION INTO THE DEVICE AND SUBSEQUENTLY BROKE DURING THE FLIPPING MANEUVER.

    Description of Event or Problem · 1

    SURGEON THREADED THE INSERTER INTO THE IMPLANT AND TURNED IT, THE PEEK INSERTER TIP BENT AT 90 DEGREE ANGLE AND THE IMPLANT DID NOT MOVE. HE WORKED ON IT FOR 45 MINUTES. THE IMPLANT THREADS WERE STRIPPED AND IT WAS NOT POSSIBLE TO RE-THREAD ANOTHER INSERTER INTO THE IMPLANT. THE DR. TRIED TO USE THE EXTRACTION TOOL TO FLIP THE IMPLANT. THE TIP ON THE EXTRACTION TOOL BROKE. THE BROKEN TIP OF THE EXTRACTION TOOL WAS RETRIEVED AND THE IMPLANT REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345488 VALEO PL/OL SURGICAL INSTRUMENT MAX AMEDICA CORP. NA 1872

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention