BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALEUTIAN

    MDR report key: 2343900 · Received October 13, 2011

    Report

    Report Number
    3004774118-2011-00013
    Event Type
    Other
    Date Received
    October 13, 2011
    Date of Event
    September 3, 2011
    Report Date
    October 13, 2011
    Manufacturer
    K2M, INC.
    Product Code
    MAX
    PMA / PMN Number
    K082698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY WAS MADE AWARE OF THIS INCIDENT ON OCTOBER 5, 2011, UPON RECEIPT OF A COPY OF THE MDR (FILED BY THE LOSS PREVENTION SPECIALIST FOR THE HOSPITAL) FROM FDA. INCIDENTALLY, THIS WAS UNFORTUNATELY BEYOND THE 30-DAY TIME-LINE. WHEN THE MDR WAS RECEIVED, INQUIRIES TO THE FIELD WERE MADE IN ORDER TO CONFIRM THE INCIDENT. CONFIRMATION OF AN INCIDENT WAS OBTAINED, HOWEVER, THE FACTS, AS DESCRIBED BY THE REP ARE SLIGHTLY DIFFERENT THAN THOSE DESCRIBED IN THE INITIAL REPORT. THIS MDR IS BEING FILED IN ORDER TO COMPLY WITH THE REGULATIONS, IN THAT THE COMPANY HAS JUST BECOME AWARE THAT A REPORTABLE INCIDENT HAS OCCURRED AND ALSO TO CLARIFY THE DESCRIPTION OF THE INCIDENT. AS REPORTED, THE ALEUTIAN INTERBODY WAS IMPACTED TOO FAR INTO THE DISK SPACE, HOWEVER, WE HAVE BEEN INFORMED THAT IT DID NOT BREAK. WE ALSO CONFIRMED THAT IT WAS LEFT IN THE PT, AS THE SURGEON FELT IT WAS STABLE AND SECURELY PLACED. HE OPTED TO INSERT A SMALLER INTERBODY IN THE REMAINING DISK SPACE.

    Description of Event or Problem · 1

    THE SURGEON INADVERTENTLY HIT THE ALEUTIAN INTERBODY/CAGE TOO FAR INTO THE DISK SPACE. THE DISK SPACE WAS REPORTEDLY VERY TIGHT AND THE SURGEON WAS UNABLE TO REMOVE OR REPOSITION THE CAGE. BECAUSE THE CAGE HAD GONE SO FAR IN, HE IMPLANTED A SMALLER CAGE TO FILL THE REMAINING DISK SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALEUTIAN INTERBODY/CAGE MAX K2M, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other