BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2750811 · Received September 14, 2012

    Report

    Report Number
    3004485144-2012-00036
    Event Type
    Other
    Date Received
    September 14, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 10, 2012
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    PMA / PMN Number
    043484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH LANX PEDICLE SCREW CONSTRUCT AT L4-S1 ON (B)(6) 2011. AT SOME POINT POST-OP, THE PATIENT FELL AND WAS EXPERIENCING PAIN. DURING THE SUBSEQUENT VISIT THE SURGEON OBSERVED HALOING AROUND THE L5/S1 SCREWS, INDICATING LOOSENING. THESE SCREWS WERE REPLACED DURING A REVISION ON (B)(6) 2012. THERE WAS NO PRODUCT PROBLEM ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI LANX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention RODS AND SET SCREWS: (B)(4)