BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESA PEDICLE SCREW

    MDR report key: 2123093 · Received September 5, 2008

    Report

    Report Number
    3004774118-2008-00006
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 30, 2008
    Manufacturer
    K2M, INC
    Product Code
    MNI
    PMA / PMN Number
    K052398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE METALLURGICALLY ANALYZED AND NO MATERIAL DEFECTS OR ABNORMALITIES IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THE COMPONENTS EARLY FAILURE. THE MFG HISTORY OF THE DEVICES HAS BEEN REVIEWED AND NO DEVIATIONS FROM SPECIFICATION IDENTIFIED. THE SCREWS WERE BOTH FRACTURED AT A POINT 3 THREADS DISTAL TO THE SCREW HEAD. THESE DEVICES ARE INTENDED TO BE A TEMPORARY FIXATION DEVICE TO AID IN THE FUSION PROCESS. BREAKAGE CAN OCCUR AND THIS IS A KNOWN COMPLICATION OF THE PROCEDURE, ESPECIALLY IN THE SACRUM, A HIGH STRESS REGION. THIS IS CAUTIONED IN THE INSTRUCTIONS FOR USE. THE SCREWS WERE ALSO OBVIOUSLY LEFT PROUD SEVERAL THREADS WHICH INCREASES THE LOADING ON THEM SUBSTANTIALLY. NO CONCLUSIONS CAN BE REACHED AT THIS TIME. THIS IS A RARE OCCURRENCE AND IS BEING MONITORED.

    Description of Event or Problem · 1

    F/U X-RAYS SHOWED BOTH S1 PEDICLE SCREWS HAD FRACTURED. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE DEVICES. THE DEVICES WERE ALL RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESA PEDICLE SCREW PEDICLE SCREW MNI K2M, INC Y37

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention