BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2915598 · Received January 10, 2013

    Report

    Report Number
    3004485144-2013-00002
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 12, 2012
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    PMA / PMN Number
    120399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED, AND THE VISUAL EXAMINATION CONFIRMED THAT THE REQUIRED ASSEMBLY PROCESS FOR THE SADDLE AND HOUSING COMPONENTS HAD BEEN PERFORMED, ALTHOUGH EXTENT OF INITIAL ENGAGEMENT COULD NOT BE VERIFIED FOLLOWING COMPONENT DISASSOCIATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO INDICATE THAT THE PRODUCT WAS MANUFACTURED OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    FOLLOWING INSERTION OF A POLYAXIAL SCREW, THE SADDLE COMPONENT WAS OBSERVED AS HAVING DISASSOCIATED FROM THE MATING HOUSING COMPONENT. THE SCREW ASSEMBLY WAS REPLACED RESULTING IN A SURGICAL DELAY OF APPROXIMATELY 20 MINUTES. THERE WAS NO REPORT OF HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15326 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI LANX, INC. 7715-6545 L552606

    Patients

    Seq Age Sex Outcome Treatment
    1