BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRIX-A LUMBAR INTEGRATED FUSION SYSTEM

    MDR report key: 19326365 · Received May 15, 2024

    Report

    Report Number
    3005031160-2024-00010
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    April 12, 2024
    Report Date
    May 15, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    OVD
    UDI-DI
    M697X08033261108PCSTR1
    PMA / PMN Number
    K171567
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT# 054940 EXPIRATION 5/01/2021 OR LOT# 048663 EXPIRATION 6/01/2020. THE EXPLANTED SYSTEM IMPLANT SCREW LOT NUMBER WAS NOT IDENTIFIED AND WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR ASSESSMENT. THE COMPLAINANT PROVIDED TWO POSSIBLE SYSTEM INTERBODY SPACER LOT NUMBERS THAT MAY HAVE BEEN RELATED TO THIS COMPLAINT. DHR REVIEWS WERE PERFORMED FOR BOTH POSSIBLE IMPLANT LOTS, WHICH WERE UNABLE TO IDENTIFY ANY MANUFACTURING ISSUES. BOTH IMPLANT LOTS MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. ONE IMPLANT LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 2/20/2015 AND THE OTHER HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 4/14/2016. THE SYSTEM SURGICAL TECHNIQUE GUIDE PROVIDES GUIDANCE ON APPROPRIATE SCREW IMPLANTATION AND STATES, "VISUAL CONFIRMATION OF THE LOCKING ARM OVER THE SCREW AND THE SCREW'S FULL SEATING IN THE FACEPLATE SHOULD BE PERFORMED." THERE ARE ALSO TWO CAUTIONARY STATEMENTS IN THE SCREW INSERTION SECTION THAT STATE, "OVER-ANGULATION OF THE SCREW BEYOND 3 DEGREES IN ANY DIRECTION MAY RESULT IN FAILURE OF THE SCREW TO ENGAGE THE IMPLANT AND/OR LOCKING ARM." AND "FAILURE TO CONFIRM THAT THE LOCKING ARM IS IN FRONT OF THE SCREW MAY RESULT IN EARLY OR LATE SCREW LOOSENING." THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE RELIABLY DETERMINED. WITHOUT THE ABILITY TO VISUALIZE THE IMPLANT LOCKING ARM POST OPERATIVELY, NO EVALUATION COULD BE PERFORMED AND IT IS UNKNOWN IF THE SYSTEM IMPLANT SCREW WAS RETAINED BY THE IMPLANT LOCKING ARM. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS OF SIMILAR NATURE WITH THIS SURGICAL SYSTEM IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THE FIELD FOR COMPLAINTS OF MIGRATED IMPLANTS. THERE IS NO ADDITIONAL INFORMATION OR EVENTS RELATED TO THIS REPORT. IF ADDITIONAL INFORMATION RELEVANT TO THIS COMPLAINT AND REGULATORY REPORT IS RECEIVED BY THE MANUFACTURER, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A POST OPERATIVE APPOINTMENT, A SYSTEM IMPLANT SCREW WAS IDENTIFIED TO HAVE MIGRATED FROM ITS INTENDED POSITION IN A SYSTEM INTERBODY SPACER. XRAY IMAGING WAS PROVIDED WHICH SHOWED AN INFERIOR IMPLANT SCREW WAS EXTENDED BEYOND THE SURFACE OF THE SYSTEM INTERBODY SPACER. A REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT INCIDENT, IN WHICH THE MIGRATED SYSTEM IMPLANT SCREW WAS REMOVED. THE LEVEL WHERE THE SYSTEM IMPLANT SCREW WAS REMOVED WAS DEEMED TO BE STABLE WITH BONY FUSION AND REQUIRED NO FURTHER SURGICAL INTERVENTION. THE PATIENT WILL BE ASSESSED WITH A STANDARD POST OP PROTOCOL FOR AN ANTERIOR APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381504 IRIX-A LUMBAR INTEGRATED FUSION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE OVD XTANT MEDICAL HOLDINGS, INC. X080-332611-08PC-STR SEE H10 SUMMARY M697X08033261108PCSTR1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization