BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1731187 · Received June 17, 2010

    Report

    Report Number
    3004485144-2010-00008
    Event Type
    Injury
    Date Received
    June 17, 2010
    Date of Event
    April 27, 2010
    Report Date
    April 27, 2010
    Manufacturer
    LANX, INC
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER INDICATED THAT THE ORIGINAL HARDWARE HAD PROVIDED THE TEMPORARY FIXATION AS INTENDED. THERE WAS NO DEVICE FAILURE LEADING TO THE REVISION SURGERY.

    Description of Event or Problem · 1

    A PT UNDERWENT A REVISION SURGERY TO REPLACE AN ANTERIOR CERVICAL PLATE BECAUSE OF CONTINUED PAIN POST-OP. THE ORIGINAL HARDWARE WAS PLACED AT C4-C6 (B)(6) 2009. THE ORIGINAL HARDWARE WAS REMOVED BECAUSE THE SURGEON DECIDED TO PERFORM A LARGER DISCECTOMY WITH MORE EXTENSIVE REMOVAL OF POSTERIOR LONGITUDINAL LIGAMENT REQUIRED, ALONG WITH THE ADDITION OF NEW ALLOGRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX ANTERIOR CERVICAL PLATE SYSTEM KWQ LANX, INC 4431-2041

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention CERVICAL ALLOGRAFT