BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI SPINELINK - II SPINAL FIXATION SYSTEM

    MDR report key: 3782155 · Received April 30, 2014

    Report

    Report Number
    0002242816-2014-00040
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    December 28, 2012
    Report Date
    April 8, 2014
    Manufacturer
    EBI, LLC.
    Product Code
    NKB
    PMA / PMN Number
    PK031355
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS UNKNOWN AS THE LOT NUMBER IS UNKNOWN, AND THEREFORE REVIEW OF THE MANUFACTURING RECORDS CANNOT BE PERFORMED. THE EXPLANTED PRODUCT WAS NOT RETURNED TO THE MANUFACTURER, THEREFORE NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    A LEGAL CLAIM WAS RECEIVED IN WHICH THE PATIENT ALLEGES THAT ONE OR TWO SCREWS WERE SUSPECTED TO HAVE FAILED VIA EXAM IN (B)(6) 2012. SUBSEQUENTLY THE SCREWS AND RELATED HARDWARE WERE EXPLANTED ON (B)(6), 2012.FILE ONE OF SEVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260430 EBI SPINELINK - II SPINAL FIXATION SYSTEM POLYDIRECTIONAL SCREW NKB EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R