BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIX-C CERVICAL INTEGRATED FUSION SYSTEM

    MDR report key: 11760704 · Received May 3, 2021

    Report

    Report Number
    3005031160-2021-00006
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 2, 2021
    Report Date
    May 3, 2021
    Manufacturer
    XTANT MEDICAL
    Product Code
    OVE
    UDI-DI
    M697T06602001
    PMA / PMN Number
    K162944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT OF THE RETURNED AWL SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY SURFACE SCRATCHES AND WORN LASER MARKINGS. THE DISTAL TIP OF THE AWL WAS FRACTURED AS REPORTED, AND THE TIP WAS DULL WITH ROTATIONAL SCRATCHES PRESENT. A FUNCTIONALITY ASSESSMENT COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED COMPLAINT INSTRUMENT, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR THE RETURNED COMPLAINT LOT AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE DEVICE MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 3/19/2014. THE DISTAL TIP OF A SYSTEM AWL COULD FRACTURE IF IT WAS SHIFTED LATERALLY WHILE BEING USED. IF THE AWL WAS INADVERTENTLY SHIFTED LATERALLY WHILE THE DISTAL TIP MAINTAINED A FIXED POSITION, IT CAN RESULT IN THE TIP FRACTURING AS IDENTIFIED ON THE COMPLAINT INSTRUMENT. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS OF SIMILAR NATURE RECEIVED IN THE PAST 12 MONTHS. THE COMPANY WILL CONTINUE TO MONITOR THIS INSTRUMENT FOR COMPLAINTS FROM THE FIELD.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2021 FOR AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING AN ACDF PROCEDURE ON (B)(6) 2021. THE COMPLAINANT REPORTED THAT WHILE PREPARING TO IMPLANT A REMOVED SYSTEM SCREW, THE DISTAL TIP OF A SYSTEM AWL FRACTURED. THERE WERE NO DEFICIENCIES IDENTIFIED WITH THE SYSTEM IMPLANT OR SCREW. THE SCREW WAS REMOVED BECAUSE THE NEUROMONITORING MACHINE IDENTIFIED A LOSS IN MEP SIGNALS AND THE SURGEON WANTED TO CONFIRM THAT THERE WAS NO OBSTRUCTION TO THE SPINAL CORD. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MDR 3005031160-2021-00005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656954 IRIX-C CERVICAL INTEGRATED FUSION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE OVE XTANT MEDICAL T066-0200 EM13M001 M697T06602001

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR