BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2103670 · Received May 20, 2011

    Report

    Report Number
    3004485144-2011-00039
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 22, 2011
    Manufacturer
    LANX, INC
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO LOCKING CAPS USED WERE ALSO RETURNED WITH THE ROD. MODEL/LOT NUMBER IDENTIFICATION ARE (B)(4), SECOND LOT UNIDENTIFIED. EVALUATION OF THE RETURNED COMPONENTS DETERMINED THAT THE LOCKING SCREWS WERE PLACED UPSIDE DOWN IN THE SCREW HOUSING. THIS CAUSED INADEQUATE LOCKING OF THE ROD AND LED TO THE SUBSEQUENT ROD MOVEMENT. LABELING FOR THE DEVICE (B)(4) PROVIDE DIRECTIONS FOR PROPER USE AND PLACEMENT OF THE LOCKING SCREWS. THE LOCKING SCREWS ARE MARKED IN A MANNER THAT IS CONSISTENT WITH THE DIRECTIONS FOR USE. FURTHER, THE THREAD DESIGNED OF THE LOCKING SCREW MAKES UPSIDE DOWN INSERTION VERY DIFFICULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS IMPLANTED WITH A PEDICLE SCREW AND ROD CONSTRUCT FOR A BILATERAL, ONE-LEVEL (L4-L5) POSTERIOR FUSION ON (B)(6) 2011. ON (B)(6) 2011, POST-OPERATIVE RADIOGRAPHS REVEALED THAT THE RIGHT ROD HAD DISASSOCIATED FROM THE L4 SCREW AND MIGRATED CAUDALLY. IT WAS REPORTED THAT THE PT WAS ASYMPTOMATIC. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2011 TO REPLACE THE ROD THAT HAD MIGRATED OUT OF THE RIGHT-SIDE PEDICLE SCREWS. THE PT IS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE SECOND SURGERY WITH NO COMPLICATIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWP LANX, INC 7701-1040 L508491

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention