BEUDAMED
    FDA Adverse Event Other Summary report: N

    MESA PEDICLE SCREW

    MDR report key: 2593972 · Received April 5, 2012

    Report

    Report Number
    3004774118-2012-00009
    Event Type
    Other
    Date Received
    April 5, 2012
    Date of Event
    March 13, 2012
    Report Date
    March 13, 2012
    Manufacturer
    K2M, INC.
    Product Code
    MNI
    PMA / PMN Number
    K052398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSTRUCT REMAINS IN THE PATIENT AT THIS TIME. THE SURGEON HAS INDICATED THAT HE PLANS TO PERFORM AND EXPLORATION TO EVALUATE THE TIGHTNESS OF THE LOCK OF THE SCREWS ON THE ROD AND DETERMINE WHETHER OR NOT THE CONSTRUCT NEEDS TO BE REVISED. THOUGH THE PATIENT HAS NOT YET BEEN REVISED, THIS INCIDENT IS BEING FILED AS A PRECAUTION.

    Additional Manufacturer Narrative · 1

    SURGEON PERFORMED AN EXPLORATORY SURGERY AND DETERMINED THAT THE ROD HAD NOT SLIPPED.

    Description of Event or Problem · 1

    MESA ROD SLIP DISCOVERED ON X-RAYS TAKEN THREE AND A POST-OPERATIVELY WHEN PATIENT CAME IN COMPLAINING OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESA PEDICLE SCREW PEDICLE SCREW MNI K2M, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention