BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOWAVE LS LUMBAR STRAIGHT

    MDR report key: 19543337 · Received June 14, 2024

    Report

    Report Number
    3012429289-2024-00001
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    March 30, 2024
    Report Date
    June 14, 2024
    Manufacturer
    HT MEDICAL, LLC DBA XENIX MEDICAL
    Product Code
    MAX
    UDI-DI
    00818345024298
    PMA / PMN Number
    K182210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE, THE LOOSENING OF THE PEDICLE SCREW SYSTEM THAT WAS USED ALLOWED THE CONSTRUCT TO LOOSEN ALLOWING THE LUMBAR IMPLANT TO MIGRATE. OTHER CONTRIBUTING FACTORS INCLUDE NOT FOLLOWING THE XENIX SYSTEM LABELING. THE SURGEON ORIGINALLY USED ANOTHER MANUFACTURER'S INTERBODY PADDLE SIZERS AND SHAVERS THAT WERE PARALLEL IN DESIGN AND NOT PROVIDED BY XENIX. THIS CAUSES THE HEIGHT OF THE DISC SPACE TO BE FALSELY MEASURED AT THE LOWEST POINT IN THE DISC SPACE, INSTEAD OF USING XENIX PROVIDED SIZER AND SHAVERS THAT ARE ANATOMIC AND MATCHING THE CONVEXITY OF THE IMPLANTS, WHICH WOULD ALLOW FOR PROPER SIZING OF THE SPACE RELATIVE TO XENIX IMPLANT DESIGNS. THE PARALLEL SHAVERS ALSO CAUSE A TROUGH TO BE CUT IN THE POSTERIOR LIP OF THE VERTEBRAL BODY WHICH, IF LEFT INTACT, ASSIST WITH A PHYSICAL BARRIER OF BONE TO PREVENT IMPLANT MIGRATION. THE SYSTEM LABELING WAS NOT FOLLOWED: EITHER XENIX IMPLANT TRIALS OR THE XENIX PADDLE DISTRACTORS ARE TO BE USED TO DETERMINE IMPLANT SIZING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SURGEON HAD A CASE IN WHICH THE LUMBAR CAGE IMPLANT HAD SHIFTED POST-OPERATIVELY. THE REP SAID THAT THE INTERBODY AT L2-3 MIGRATED POSTERIORLY. IMAGING REVEALED THE POSTERIOR MIGRATED IMPLANT AS WELL AS SIGNS OF POTENTIAL SCREW LOOSENING AT THE L2 SCREW. DURING THE REVISION SURGERY, IT WAS DISCOVERED THAT THE L2 PEDICLE SCREW CAPS IN THE PEDICLE SCREW TULIP USED FOR FIXATION HAD LOOSENED ALLOWING THE ROD TO SHIFT. NOTE - THE PEDICLE SCREW SYSTEM IS FROM ANOTHER MANUFACTURER (UNKNOWN) AND IS NOT A XENIX MEDICAL PRODUCT. DURING THE REVISION PROCEDURE, THE LUMBAR CAGE IMPLANT WAS SHIFTED BACK INTO POSITION AND THE SET SCREW WAS REPLACED AND THE CONSTRUCT WAS TIGHTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783698 NEOWAVE LS LUMBAR STRAIGHT INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX HT MEDICAL, LLC DBA XENIX MEDICAL 23-LCT-2211 JI6540 00818345024298

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention PEDICLE SCREW FIXATION SYSTEM