BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE RIDGE

    MDR report key: 3150162 · Received June 6, 2013

    Report

    Report Number
    3004774118-2013-00015
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    February 23, 2013
    Report Date
    June 6, 2013
    Manufacturer
    K2M, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K113328
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REPORTEDLY REVISED ON (B)(6) 2013, HOWEVER, ALL OF THE SPECIFICS WERE NOT MADE AVAILABLE TO THE MANUFACTURER UNTIL (B)(4) 2013. THE EXPLANTED PLATE AND SCREWS (CAT#S 3901-04012C AND 3901-04312C) WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE LOT NUMBER OF THE PLATE AND SCREWS WERE ALSO NOT MADE AVAILABLE HOWEVER, A GENERAL REVIEW OF OVERALL MANUFACTURING RECORDS FOR THIS SYSTEM HAS BEEN PERFORMED AND NO MANUFACTURING OR MATERIAL DISCREPANCIES HAVE BEEN FOUND. WITHOUT THE ACTUAL DEVICE OR X-RAYS, NO FIRM CONCLUSIONS CAN BE DRAWN AS TO THE ROOT CAUSE OF THE SCREW BACK-OUT. A COMPANY REPRESENTATIVE HAS MET WITH THE SURGEON TO REVIEW THE SURGICAL TECHNIQUE AND TO TRY TO DETERMINE WHAT MAY HAVE CONTRIBUTED TO THE EVENT. WE WILL CONTINUE TO MONITOR ISSUES OF THIS NATURE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    BLUE RIDGE SCREW BACKED OUT APPROXIMATELY TWO MONTHS POST-OPERATIVELY. THE PATIENT WAS REVISED; HOWEVER, THE SPECIFICS OF THIS INCIDENT WERE NOT MADE AVAILABLE IN FULL TO THE MANUFACTURER UNTIL (B)(4) 2013 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251018 BLUE RIDGE CERVICAL PLATE KWQ K2M, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention