BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIX-A LUMBAR INTEGRATED FUSION SYSTEM

    MDR report key: 10482761 · Received September 2, 2020

    Report

    Report Number
    3005031160-2020-00019
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 7, 2020
    Report Date
    September 2, 2020
    Manufacturer
    XTANT MEDICAL
    Product Code
    HXX
    UDI-DI
    M697N600004731
    PMA / PMN Number
    K171567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 FOR A SYSTEM HANDLE IN WHICH THE PROXIMAL CAP FRACTURED FROM THE BODY OF THE INSTRUMENT WHILE THE SURGEON WAS STRIKING IT WITH THE MALLET. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. A VISUAL ASSESSMENT OF THE RETURNED HANDLE SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY WORN LASER MARKINGS AND SURFACE SCRATCHES. THE PROXIMAL CAP OF THE RETURNED HANDLE WAS FRACTURED FROM THE BODY OF THE INSTRUMENT AND NOT RETURNED. THE PROXIMAL CAP OF THE SYSTEM HANDLE IS A T-SHAPED PLUG THAT IS SECURED INTO THE END OF THE HANDLE, SURROUNDED BY A SILICONE HANDLE. AN IMPACT TO THE EDGE OF THE CAP MAY CAUSE THE CAP TO FLEX ON THE SILICONE HANDLE AND RESULT IN A FRACTURED CAP. THE CONDITION OF THE PROXIMAL CAP COULD NOT BE CONFIRMED DUE TO IT NOT BEING RETURNED FOR COMPLAINT ASSESSMENT. THE COMPLAINT INVESTIGATION SUGGESTS THE POSSIBILITY THAT THE EDGE OF THE CAP WAS IMPACTED, RESULTING IN AN INSTRUMENT MALFUNCTION.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 FOR A SYSTEM HANDLE IN WHICH THE PROXIMAL CAP FRACTURED FROM THE BODY OF THE INSTRUMENT, WHILE THE SURGEON WAS STRIKING IT WITH THE MALLET. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948549 IRIX-A LUMBAR INTEGRATED FUSION SYSTEM RATCHETING SCREWDRIVER HANDLE HXX XTANT MEDICAL N60000473 76836 M697N600004731

    Patients

    Seq Age Sex Outcome Treatment
    1 Other