BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX FUSION SYSTEM

    MDR report key: 2651991 · Received July 3, 2012

    Report

    Report Number
    3004485144-2012-00022
    Event Type
    Other
    Date Received
    July 3, 2012
    Date of Event
    June 5, 2012
    Report Date
    June 12, 2012
    Manufacturer
    LANX, INC.
    Product Code
    MAX
    PMA / PMN Number
    103666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE RETURNED DRAW RODS DID NOT INDICATE ANY ISSUES WITH THE INSTRUMENT. THE INSTRUMENT THREADS WERE RE-INSPECTED AND FOUND TO MEET SPECIFICATION. A DHR REVIEW INDICATES NO DISCREPANCIES WHICH WOULD HAVE CONTRIBUTED TO THE EVENT. POSSIBLE CROSS THREADING MAY HAVE OCCURRED, CAUSING DIFFICULTY OF IMPLANT REMOVAL.

    Description of Event or Problem · 1

    THE SURGEON EXPERIENCED A 20 MINUTE SURGICAL DELAY WHILE ATTEMPTING TO REMOVE THE INTERBODY IMPLANT FROM THE INSERTER AFTER IMPLANTATION INTO THE DISC SPACE. THE SURGEON WAS ABLE TO REMOVE THE DRAW ROD AND COMPLETE THE CASE SUCCESSFULLY WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX FUSION SYSTEM DRAW ROD MAX LANX, INC. 8732-6106-005 L555566

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention