BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX ALIF INTERVERTEBRAL BODY FUSION SYSTEM

    MDR report key: 2713515 · Received August 22, 2012

    Report

    Report Number
    3004485144-2012-00028
    Event Type
    Other
    Date Received
    August 22, 2012
    Date of Event
    July 25, 2012
    Report Date
    July 29, 2012
    Manufacturer
    LANX, INC.
    Product Code
    OVE
    PMA / PMN Number
    071344
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES NO DISCREPANCIES WHICH WOULD HAVE CONTRIBUTED TO THE EVENT. VISUAL INSPECTION OF RETURNED DEVICE INDICATES THIRD BODY DEBRIS BETWEEN THREADS, WHICH LEAD TO DIFFICULTY LOOSENING THREADS AND SUBSEQUENT TORSION FAILURE.

    Description of Event or Problem · 1

    DURING AN ALIF SURGERY, THE SURGEON TRIALED THE DISC SPACE WITH A TRIAL COMPONENT ATTACHED TO THE INSERTER. THE INSERTER DRAW ROD BECAME DETACHED FROM THE INSERTER. THE SURGEON HAD TO GO BACK AND TRY TO CONNECT AGAIN IN ORDER TO REMOVE THE TRIAL. THE SURGEON WAS ABLE TO RECONNECT THE ROD. WHEN THE SURGEON WAS REMOVING THE TRIAL, IT BROKE OFF INSIDE OF THE TRIAL AND GOT STUCK. SURGEON HAD TO USE ANOTHER INSTRUMENT TO REMOVE THE TRIAL. SURGERY WAS EXTENDED BY 15 MINUTES WITH NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX ALIF INTERVERTEBRAL BODY FUSION SYSTEM DRAW ROD OVE LANX, INC. L564752

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention