BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX CERVICAL SA INTERVERT BODY FUSION SYS

    MDR report key: 2717692 · Received August 24, 2012

    Report

    Report Number
    3004485144-2012-00030
    Event Type
    Other
    Date Received
    August 24, 2012
    Date of Event
    August 15, 2012
    Report Date
    August 16, 2012
    Manufacturer
    LANX, INC
    Product Code
    OVE
    PMA / PMN Number
    112388
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. SCREW PLACEMENT AND DRILLING AT AN EXTREME ANGLE ARE POSSIBLE CONTRIBUTORS. 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 SURGEON WAS ATTEMPTING TO DRIVE A SCREW THROUGH THE PLATE WHEN THE PLATE CAME OFF THE INTERBODY COMPONENT WHILE DRIVING THE SCREW. AFTER REPLACING THE COMPONENTS, THE SURGEON WAS DRILLING AND CAUSED A SECOND PLATE TO DISENGAGE THE INTERBODY COMPONENT. THERE WAS A 20 MINUTE SURGERY DELAY TO REPLACE THE COMPONENT. THE SURGERY WAS COMPLETED WITH OTHER COMPONENTS IN THE SYSTEM WITHOUT FURTHER INCIDENT.

    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 INTERBODY COMPONENTS INVOLVED: 8401-0507