BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX CERVICAL SA INTERVERT. BODY FUSION SYS.

    MDR report key: 2717781 · Received August 23, 2012

    Report

    Report Number
    3004485144-2012-00029
    Event Type
    Other
    Date Received
    August 23, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 9, 2012
    Manufacturer
    LANX, INC.
    Product Code
    OVE
    PMA / PMN Number
    112388
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. A REVIEW OF THE SYSTEM SURGICAL TECHNIQUE OUTLINES DISENGAGEMENT OF THE COMPONENTS AS A POTENTIAL OCCURRENCE.

    Description of Event or Problem · 1

    DURING SURGERY, THE PLATE SEPARATED FROM THE PEEK INTERBODY COMPONENT AFTER THE DEVICE WAS PLACED IN THE INTERBODY SPACE, WHICH RESULTED IN A ONE HOUR DELAY OF SURGERY TO USE ANOTHER MANUFACTURER'S SYSTEM TO COMPLETE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX CERVICAL SA INTERVERT. BODY FUSION SYS. CERVICAL SA INTERVERT. BODY FUSION SYS. OVE LANX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 8403-0007| 8401-0007| 8401-0506