BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIX-C CERVICAL INTEGRATED FUSION SYSTEM

    MDR report key: 3882892 · Received June 19, 2014

    Report

    Report Number
    3005031160-2014-00006
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 13, 2014
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    OVE
    PMA / PMN Number
    K131951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION, X-SPINE HAD CONFIRMED THAT THE TIP OF THE GUIDED ANGLED AWL HAD BROKEN OFF AS INDICATED BY THE COMPLAINANT. THE OVERALL PHYSICAL APPEARANCE OF THE GUIDED ANGLE AWL WOULD SUGGEST THAT IT WASN'T USED VERY FREQUENTLY (I.E. NO SCRATCHES, DINGS OR DISCOLORATION PRESENT). HOWEVER, THE OBSERVED CONDITION MAY BE REPLICATED IF THE INSERTER WAS NOT USED TO GUIDE THE AWL INTO THE APPROPRIATE POSITION OR IF EXCESSIVE LATERAL FORCE WAS USED WHILE ALIGNING THE FLAT ON THE DISTAL TIP OF THE AWL WITH THE LOCKING ARM ON THE IMPLANT. ACCORDING TO THE IRIX-C CERVICAL INTEGRATED FUSION SYSTEM - SURGICAL TECHNIQUE - STEP 9: SCREW HOLE PREPARATION - AWL "USE THE AWL TO PREPARE THE HOLE. A STRAIGHT AND FIXED ANGLE AWL ARE OFFERED. PUSH DOWN ON THE AWL HANDLE TO PUSH OUT THE AWL TIP. USE THE INSERTER TO GUIDE THE AWL INTO THE APPROPRIATE POSITION. NOTE: ALIGN THE FLAT ON THE DISTAL TIP OF THE AWL WITH THE LOCKING ARM ON THE IMPLANT. CAUTION: WHILE PLACING THE BONE AWL THROUGH THE INSERTER OR IMPLANT, ENSURE THAT SUCH PLACEMENT DOES NOT RESULT IN POSTERIOR DISPLACEMENT OF THE IMPLANT. POSTERIOR DISPLACEMENT OF THE IMPLANT CAN RESULT IN NEUROLOGICAL INJURY." (B)(4).

    Description of Event or Problem · 1

    THE TIP OF THE GUIDED ANGLE AWL HAD BROKEN OFF IN THE SECOND PILOT HOLE DURING THE SURGICAL PROCEDURE. THE SURGEON HAD DRILLED THE FIRST PILOT HOLE AND IMPLANTED THE FIRST SCREW WITHOUT ANY ISSUES. HOWEVER, WHEN THE SURGEON BEGAN DRILLING THE SECOND PILOT HOLE IN THE PATIENTS HARD BONE, THE TIP OF THE GUIDED ANGLE AWL HAD BROKEN OFF IN THE PILOT HOLE. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN AWL TIP FROM THE PILOT HOLE; HOWEVER, IT CAUSED A 30-40 MINUTE SURGICAL DELAY. WHEN THE SURGEON TRIED TO PLACE THE SECOND SCREW IN THE (ENLARGED) PILOT HOLE, THE SCREW WOULD NOT WORK. THE SURGEON TRIED USING THE RESCUE SCREW IN THE SECOND PILOT HOLE, BUT THE PILOT HOLE WAS STILL TOO LARGE FOR THE RESCUE SCREW TO FUNCTION PROPERLY. THEREFORE, THE SURGEON HAD COMPLETED THE PROCEDURE WITH ONLY ONE SCREW IMPLANTED AT THE SURGICAL SITE. THE PATIENT DID NOT SUSTAIN ANY INJURIES AS A RESULT OF THE GUIDED ANGLE AWL TIP BREAKING OFF IN THE SECOND PILOT HOLE OR NOT BEING ABLE TO IMPLANT A SECOND SCREW AT THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361536 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