BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1662367 · Received April 15, 2010

    Report

    Report Number
    3004485144-2010-00002
    Event Type
    Injury
    Date Received
    April 15, 2010
    Date of Event
    March 17, 2010
    Report Date
    March 17, 2010
    Manufacturer
    LANX, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: THE DEVICE WAS RETURNED WITH THE ROD STILL SECURED IN THE PEDICLE SCREW. A FUNCTIONAL TEST TO LOOSEN THE CONSTRUCT FOUND THAT THE SET SCREW WAS OVERLY TIGHT ON THE ROD. THE AMOUNT OF TORQUE REQUIRED TO LOOSEN THE SET SCREW WAS GREATER THAN THE SPECIFIED TORQUE USED FOR TIGHTENING. A DIMENSIONAL INSPECTION OF THE COMPONENTS WAS PERFORMED. HOWEVER, THE INSPECTION IS INCONCLUSIVE BECAUSE OF THE USED CONDITION OF THE COMPONENTS. FURTHER DISCUSSION WITH THE SURGEON INDICATES THAT THE SET SCREW MAY HAVE BEEN TIGHTENED WITH A RATCHETING HANDLE INSTEAD OF THE PROVIDED TORQUE LIMITING HANDLE. THIS INFORMATION SUGGESTS A POSSIBILITY THAT THE SET SCREW WAS TIGHTENED ABOVE THE SPECIFIED TORQUE VALUE FOR THE DEVICE. GIVEN THE PATIENT'S OSTEOPOROTIC CONDITION, IT IS INCONCLUSIVE WHETHER THE TIGHT SET SCREW CONTRIBUTED TO THE BREAK OF THE PATIENT'S L4 PEDICLE AND VERTEBRAL BODY.

    Description of Event or Problem · 1

    DURING A SURGERY TO IMPLANT A SPINAL FIXATION SYSTEM AT L4-L5, THE SURGEON BROKE THE PATIENT'S PEDICLE AND A PORTION OF THE L4 VERTEBRAL BODY. THE BREAKAGE OCCURRED WHEN THE SURGEON ATTEMPTED TO MAKE AN ADJUSTMENT TO THE CONSTRUCT. THE REPORT INDICATES THAT THE SURGEON COULD NOT LOOSEN THE SET SCREW IN THE PEDICLE SCREW HOUSING. THE PIECE OF BONE WAS REMOVED AND THE CONSTRUCT WAS COMPLETED UNILATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWQ LANX, INC. 7716-6545 L510704

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other PEEK INTERBODY SPACER