BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIX-C CERVICAL INTEGRATED FUSION SYSTEM

    MDR report key: 3845291 · Received June 3, 2014

    Report

    Report Number
    3005031160-2014-00005
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 30, 2014
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    OVE
    PMA / PMN Number
    K131951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE PROCEDURE PERFORMED ON (B)(6) 2014 WAS AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C4-7. THE SURGEON WAS USING THE MODULAR INSERTER HANDLE AND ATTACHED INSERTER TIP TO INSERT AND POSITION THE IMPLANTED PLATE WITHIN THE SURGICAL CAVITY. THE SURGEON HAD INSERTED AND POSITIONED THE PLATE AS DESIRED; HOWEVER, WHILE THE INSERTER HANDLE AND ATTACHED TIP WAS FULLY OPENED, THE SURGEON COULD NOT GET THE INSERTER DETACHED FROM THE PLATE. EVENTUALLY, THE SURGEON WAS ABLE TO GET THE INSERTER HANDLE AND TIP DETACHED FROM THE PLATE. ONCE THE INSERTER HANDLE AND ATTACHED TIP WERE REMOVED FROM THE SURGICAL CAVITY, THE SURGEON SELECTED A PLATE FROM THE IMPLANT CADDY AND ATTACHED IT TO THE INSERTER HANDLE WITH THE APPROPRIATELY SIZED TIP TO SEE IF THE ISSUE COULD BE REPLICATED OUTSIDE OF THE SURGICAL CAVITY - THE SURGEON OBTAINED THE SAME RESULT "IMPLANT COULD NOT BE DETACHED FROM THE INSERTER HANDLE AND ATTACHED TIP WHILE FULLY OPENED." THE SURGEON HAD INDICATED THAT IT APPEARED TO BE "BOUND-UP." AS A RESULT, THE SURGEON HAD USED THE BACK-UP INSERTER HANDLE AND INSERTER TIP FROM THE TRAY SET TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED WITHOUT ANY SIGNIFICANT DELAYS OR ANY FURTHER ISSUES. THE PATIENT DID NOT SUSTAIN ANY INJURIES AS A RESULT OF THE INSERTER HANDLE AND TIP NOT INITIALLY DETACHING FROM THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325044 IRIX-C CERVICAL INTEGRATED FUSION SYSTEM CERVICAL INTEGRATED FUSION SYSTEM OR STAND-ALONE CERVICAL CAGE OVE X-SPINE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other