BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX ANCHORED ALIF SCREW

    MDR report key: 2197686 · Received July 27, 2011

    Report

    Report Number
    3004485144-2011-00051
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 7, 2011
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER INDICATED THAT POSSIBLE MISALIGNMENT OF THE DRIVER WITH THE SCREW CONTRIBUTED TO THE STRIPPING, AS WELL AS EXTREMELY HARD BONE QUALITY. A REVIEW OF THE DHR INDICATES THAT NO DISCREPANCIES WERE NOTED WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF (B)(4) INDICATES ADEQUATE INSTRUCTION FOR USE OF THE DRIVERS TO INSERT A SCREW.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE SCREW WOULD NOT ADVANCE COMPLETELY INTO THE PLATE, ADDITIONAL FORCE WAS REQUIRED IN AN ATTEMPT TO DRIVE THE SCREW. THE SCREW WAS STRIPPED DURING ATTEMPTED IMPLANTATION. SURGERY WAS EXTENDED APPROXIMATELY FIFTEEN MINUTES IN ORDER TO REMOVE THE SCREW WITH PLIERS AND IMPLANT ANOTHER SCREW. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX ANCHORED ALIF SCREW ANCHORED ALIF SCREW MNI LANX, INC. 8503-4530 L537194

    Patients

    Seq Age Sex Outcome Treatment
    1