BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2040992 · Received March 25, 2011

    Report

    Report Number
    3004485144-2011-00028
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    LANX, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED, THEREFORE, NO FURTHER EVAL COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE PT UNDERWENT A F/U SURGERY ON (B)(6) 2011 AND AN INTERSPINOUS FIXATION DEVICE WAS REMOVED. THE LEVEL WAS THEN FIXATED WITH A FACET SCREW. THE INTERSPINOUS FIXATION DEVICE WAS NOT REPLACED. IT WAS NOTED BY THE REPORTER THAT THERE WAS NO MALFUNCTION OF THE DEVICE. THE REPORTER ALSO NOTED THAT THE PT HAD UNDERGONE OTHER SPINAL SURGERIES PRIOR TO PLACEMENT OF THE INTERSPINOUS FIXATION DEVICE BUT DETAILS OF THESE SURGERIES IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINOUS PROCESS FUSION PLATE KWP LANX, INC. 6212-0006

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention