BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1913861 · Received November 29, 2010

    Report

    Report Number
    3004485144-2010-00053
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 1, 2010
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE UNDERSTANDING OF THE EVENT, AS REPORTED BY THE INITIAL REPORTER, RE-ADJUSTMENT OF THE CONSTRUCT WAS ATTEMPTED AFTER FINAL TIGHTENING. THE SURGEON DID NOT WANT TO APPLY EXCESSIVE TORQUE WITH THE PROVIDED INSTRUMENTS AND CHOSE TO CUT THE ROD FOR REMOVAL. THE EVALUATION OF THE RETURNED SET SCREW CONFIRMED THE EVENT OF DIFFICULTY TO LOOSEN THE CONSTRUCT. THE TORQUE REQUIRED TO LOOSEN THE CONSTRUCT (46.5 IN-LBS) WAS HIGHER THAN THE MAXIMUM TORQUE TO TIGHTEN THE CONSTRUCT (25.2 IN-LBS). THE DIFFICULTY LOOSENING THE SET SCREW MAY HAVE BEEN DUE TO DEBRIS TRAPPED BETWEEN THE SCREW AND HOUSING, OR DEFORMATION OF THE HOUSING DURING TIGHTENING AND/OR LOOSENING. THE DIFFICULTY IN ADJUSTMENT OF THE TWO POLYAXIAL SCREWS AFTER LOOSENING WAS LIKELY CAUSED BY COMPRESSION OF THE HOUSING AND SCREW INTERFACE DUE TO THE FORCES APPLIED DURING ORIGINAL TIGHTENING OF THE CONSTRUCT PRIOR TO ATTEMPTED RE-ADJUSTMENT. THIS INITIAL TIGHTENING RESULTED IN A RIGID CONSTRUCT BETWEEN THE SUBCOMPONENTS OF THE POLYAXIAL SCREW.

    Description of Event or Problem · 1

    DURING SURGERY FOR FIXATION OF SPINE LEVELS C3-C6, ADJUSTMENT AND REPOSITIONING OF THE ROD/SCREW CONSTRUCT WAS CONSIDERED NECESSARY BY THE SURGEON AFTER FINAL TIGHTENING OF THE SET SCREWS. WHEN TRYING TO LOOSEN A SET SCREW ON THE C6 LEVEL, THE SURGEON COULD NOT LOOSEN THE SET SCREW AND SUBSEQUENTLY HAD TO CUT THE ROD IN ORDER TO REMOVE THE ENTIRE POLYAXIAL SCREW FROM THE SITE. UPON REMOVAL OF THE OTHER FOUR SET SCREWS WHICH LOOSENED WITHOUT INCIDENT, THE HOUSING OF 2 POLYAXIAL SCREWS COULD NOT FREELY ROTATE IN ORDER TO ADJUST THE POSITION OF THE ROD/SCREW CONSTRUCT. THE SURGEON SUCCESSFULLY REMOVED THE POLYAXIAL SCREWS WHICH COULD NOT BE ADJUSTED. DURING THE REMOVAL PROCESS BY BACKING OUT THE SCREWS, MINOR DAMAGE TO THE LATERAL MASS OCCURRED. THE SURGERY WAS COMPLETED WITH A ROD/SCREW CONSTRUCT FROM C3-C5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM MNI LANX, INC. 7902-1000 L520484

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention