BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE RIDGE

    MDR report key: 2850343 · Received November 15, 2012

    Report

    Report Number
    3004774118-2012-00024
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 15, 2012
    Manufacturer
    K2M, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K113329
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO (INCLUDING X-RAYS) HAVE BEEN REQUESTED AS PART OF THE EVAL. THE REP INDICATED THAT THE PRODUCT WILL NOT BE RETURNING. NO FIRM CONCLUSIONS CAN BE DRAWN REGARDING A POSSIBLE CAUSE SO EVEN THOUGH THE PT HAD FUSED AND THE PLATE/SCREWS ARE INTENDED TO SERVICE AS AN ADJUNCT TO FUSION, THE INCIDENT IS BEING REPORTED AS A PRECAUTION DUE TO THE LIMITED AMOUNT OF AVAILABLE INFO TO DATE.

    Description of Event or Problem · 1

    TWO VARIABLE SCREWS BACKED OUT OF A BLUE RIDGE PLATE APPROX 8 MONTHS POST-OP. THE PT WAS REVISED BUT NOT RE-INSTRUMENTED AS THE PT HAD FUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE RIDGE CERVICAL SCREW KWQ K2M, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention