BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 3530538 · Received November 14, 2013

    Report

    Report Number
    3004485144-2013-00034
    Event Type
    Other
    Date Received
    November 14, 2013
    Date of Event
    October 16, 2013
    Report Date
    October 16, 2013
    Manufacturer
    LANX, INC.
    Product Code
    NKB
    PMA / PMN Number
    120399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE ASSOCIATED DHR FOUND NO DEVICE NONCONFORMITIES THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. THE PRODUCT LABELING IDENTIFIES IMPLANT BREAKAGE OR FAILURE AS POSSIBLE COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS PERFORMED TO ADDRESS TWO BROKEN PEDICLE SCREWS ONE YEAR AFTER BEING IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591708 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB LANX, INC. 7716-6545 L514028

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR