BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE RIDGE

    MDR report key: 3231371 · Received July 17, 2013

    Report

    Report Number
    3004774118-2013-00022
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    January 14, 2013
    Report Date
    July 5, 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 LOCKING CLIP WAS REPORTEDLY DAMAGED INTRA-OPERATIVELY DURING SCREW INSERTION ON (B)(6) 2012 AND THE SURGEON REMOVED A PORTION OF THE BROKEN CLIP HOWEVER, LEFT THE OTHER PIECE IN THE PLATE. THE SCREW HOLE WHERE THE CLIP BROKE WAS LEFT EMPTY AND PATIENT FELT TO BE STABLE ENOUGH WITH 5 SCREWS. APPROXIMATELY ONE TO TWO WEEKS POST-OPERATIVELY, THE PATIENT WAS REPORTEDLY TRANSPORTED BY AMBULANCE TO THE ER OF A DIFFERENT HOSPITAL AND TREATED FOR A PERFORATED ESOPHAGUS. THE REMAINING PORTION OF THE BROKEN CLIP WAS REPORTEDLY REMOVED AT THAT TIME. THE REPRESENTATIVE DOES NOT BELIEVE THE PATIENT HAS BEEN REVISED AS HE HAS NOT BEEN SEEN AGAIN BY THE INITIAL SURGEON. THE LOT NUMBER OF THE PLATE AND SCREWS WERE ALSO NOT YET MADE AVAILABLE. THIS MDR IS BEING FILED AS A PRECAUTION, HOWEVER, NO INFORMATION HAS BEEN PROVIDED TO DATE THAT DEFINITIVELY CONFIRMS THAT THE PIECE OF METAL REPORTEDLY REMOVED WAS PART OF A K2M PRODUCT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT WHO WAS IMPLANTED WITH A BLUE RIDGE PLATE PRESENTED IN THE ER APPROXIMATELY 1-2 WEEKS POST-OPERATIVELY, COUGHING UP BLOOD. PATIENT UNDERWENT SURGERY FOR A PERFORATED ESOPHAGUS AND A PIECE OF THE BLUE RIDGE LOCKING CLIP WAS REPORTEDLY REMOVED. MANUFACTURER JUST BECAME AWARE OF THIS INCIDENT ON (B)(6) 2013 AND ADDITIONAL DETAILS ARE STILL BEING OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330879 BLUE RIDGE CERVICAL PLATE KWQ K2M, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention