BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOWAVE LS LUMBAR STRAIGHT

    MDR report key: 19541352 · Received June 14, 2024

    Report

    Report Number
    3012429289-2024-00002
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    May 13, 2024
    Report Date
    June 14, 2024
    Manufacturer
    HT MEDICAL, LLC DBA XENIX MEDICAL
    Product Code
    MAX
    UDI-DI
    00818345024311
    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 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 WHERE THE LUMBAR CAGE IMPLANT HAD SHIFTED POST-OPERATIVELY. THE REP STATED THAT THE PATIENT ORIGINALLY HAD A L4-5 TLIF UTILIZING A 13MM IMPLANT. PATIENT REQUIRED A REVISION SURGERY BECAUSE THE IMPLANT MIGRATED POSTERIORLY THROUGH THE DISC PREP PATHWAY. IN THE REVISION SURGERY, THE SURGEON INCREASED THE HEIGHT OF THE IMPLANT TO A 15MM HEIGHT, WHICH IS EVIDENT IN THE A/P XRAY WHERE THERE IS LESS GAP ABOVE AND BELOW THE IMPLANT AS WAS PREVIOUSLY PRESENT ON THE 13MM. THE PATIENT AGAIN HAD THE 15MM IMPLANT MOVE POSTERIORLY AND REQUIRED A REVISION SURGERY. THE SURGEON REMOVED THE 15MM IMPLANT AND REPLACED IT WITH A ANOTHER MANUFACTURER'S EXPANDABLE TLIF IMPLANT. THIS IS ONE OF TWO RELATED MDRS FOR THIS PATIENT (THIS IS FOR THE FIRST REVISION PROCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125159 NEOWAVE LS LUMBAR STRAIGHT INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX HT MEDICAL, LLC DBA XENIX MEDICAL 23-LCT-2213 JI6404 00818345024311

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention PEDICLE SCREW SYSTEM