BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX POSTERIOR CERVICOTHORACIC SFS

    MDR report key: 2456315 · Received February 13, 2012

    Report

    Report Number
    3004485144-2012-00008
    Event Type
    Other
    Date Received
    February 13, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 2, 2012
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    PMA / PMN Number
    071905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED INSTRUCTIONS FOR USE LISTS SECOND SURGERY AS A POSSIBLE COMPLICATION.

    Description of Event or Problem · 1

    THE PT UNDERWENT REVISION SURGERY TO REPLACE POLYAXIAL SCREWS THAT WERE DETERMINED TO BE MISPLACED. THE NEW SCREWS WERE INSERTED AT THE SAME LEVEL AS THE ORIGINAL SCREWS, BUT REDIRECTED AT A MORE OPTIMAL TRAJECTORY. NO INJURY TO THE PT WAS REPORTED. NO PRODUCT PROBLEM ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX POSTERIOR CERVICOTHORACIC SFS SPINAL FIXATION SYSTEM MNI LANX, INC. 7911-3536/40

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention