BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESA

    MDR report key: 2850344 · Received November 15, 2012

    Report

    Report Number
    3004774118-2012-00025
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    September 28, 2012
    Report Date
    November 15, 2012
    Manufacturer
    K2M, INC.
    Product Code
    MNI
    PMA / PMN Number
    K052398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REP HAS INDICATED THAT THE SURGEON DOES NOT VIEW THIS AS AN IMPLANT FAILURE DUE TO THE ACTIVITY THE PT WAS UNDERGOING. THE CONSTRUCT WAS EXTENDED FROM T11 TO L3. THE SURGEON REPORTEDLY NOTED THAT THE ROD WAS STILL APPROX 50% IN THE HEAD OF THE SCREW HOWEVER, THE SCREW APPEARED FULLY LOCKED. THE ROD REPORTEDLY EXHIBITED SOME DAMAGE FROM THE SCREW SLIDING ON IT AND THERE WAS SOME METAL WEAR DEBRIS NOTED IN THE WOUND SITE. ADD'L INFO (INCLUDING X-RAYS AND THE PARTS) HAVE BEEN REQUESTED AS PART OF THE EVAL. NO FIRM CONCLUSIONS CAN BE DRAWN REGARDING THE ROOT CAUSE THROUGH IT IS LIKELY THAT JUMPING ON THE TRAMPOLINE SO SOON AFTER SURGERY WAS A CONTRIBUTORY FACTOR. NONETHELESS, THE INCIDENT IS BEING REPORTED AS A PRECAUTION DUE TO THE LIMITED AMOUNT OF AVAILABLE INFO TO DATE.

    Description of Event or Problem · 1

    THE DISTAL END OF THE ROD CAME LOOSE FROM A MESA SCREW APPROX TWO TO THREE WEEKS POST-OPERATIVELY. THE PT HAD REPORTEDLY BEEN JUMPING ON A TRAMPOLINE. THE PT WAS REVISED ON (B)(6) 2012 HOWEVER THE MANUFACTURE WAS NOT MADE AWARE UNTIL (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention