BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIX-C CERVICAL INTEGRATED FUSION SYSTEM

    MDR report key: 11760706 · Received May 3, 2021

    Report

    Report Number
    3005031160-2021-00005
    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
    M697T06602131
    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 SCREW REMOVAL INSTRUMENT SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY SURFACE SCRATCHES AND WORN LASER MARKINGS. THE DISTAL TIP OF THE SCREW REMOVAL INSTRUMENT WAS FRACTURED AND TWISTED IN A MANNER THAT INDICATES IT WAS BEING ROTATED COUNTERCLOCKWISE WHEN THE MALFUNCTION OCCURRED. 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 (B)(6) 2014. THE DISTAL TIP OF A SCREW REMOVAL INSTRUMENT COULD FRACTURE IF THE SHAFT OF THE INSTRUMENT WAS ROTATED WITHOUT THE SLEEVE OF THE INSTRUMENT APPROPRIATELY ROTATED TO ALLOW FOR THE IMPLANT SCREW TO PASS BY THE LOCKING ARM OF THE IMPLANT. IF THE SLEEVE OF THE SCREW REMOVAL INSTRUMENT IS NOT APPROPRIATELY ROTATED TO ALLOW THE IMPLANT SCREW TO PASS, THE APPLIED ROTATIONAL FORCE MAY BE CONCENTRATED ON THE DISTAL TIP AND COULD RESULT IN AN INSTRUMENT MALFUNCTION. 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 A SURGEON WAS REMOVING A SYSTEM SCREW, THE DISTAL TIP OF A SCREW REMOVAL INSTRUMENT 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 3005031160-2021-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656957 IRIX-C CERVICAL INTEGRATED FUSION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE OVE XTANT MEDICAL T066-0213 2975-01 M697T06602131

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR