BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2434325 · Received January 27, 2012

    Report

    Report Number
    3004485144-2012-00006
    Event Type
    Injury
    Date Received
    January 27, 2012
    Report Date
    January 6, 2012
    Manufacturer
    LANX, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES RETURNED. INSUFFICIENT INFORMATION SUPPLIED AFTER MULTIPLE FOLLOW-UP ATTEMPTS SUPPLIED IN ORDER TO INVESTIGATE EVENT. A REVIEW OF PERTINENT INSTRUCTIONS FOR USE INDICATES THAT THE STERILIZATION PARAMETERS ARE ACCURATELY SPECIFIED FOR THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE PATIENTS EXPERIENCED POSITIVE CULTURES FOR INFECTION APPROXIMATELY 2-3 WEEKS AFTER INITIAL IMPLANTATION OF HARDWARE AT L5-S1. PATIENTS WERE PROVIDED ANTIBIOTICS FOR TREATMENT. NO FURTHER COMPLICATIONS WERE NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention