BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIX-C CERVICAL INTEGRATED FUSION SYSTEM

    MDR report key: 14456977 · Received May 20, 2022

    Report

    Report Number
    3005031160-2022-00020
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 28, 2022
    Report Date
    May 19, 2022
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    OVE
    UDI-DI
    M697T06602051
    PMA / PMN Number
    K162944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT OF THE RETURNED COMPLAINT AWL SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY WORN LASER MARKINGS AND SURFACE SCRATCHES. THERE WAS AN IMPACT MARK PRESENT ON THE FRACTURED AWL PORTION, AND THE DISTAL TIP WAS WORN. THE DISTAL TIP OF THE RETURNED COMPLAINT AWL WAS FRACTURED AS REPORTED. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED INSTRUMENT, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR THE RETURNED AWL COMPLAINT LOT AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE DEVICE LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 7/02/2014. THE COMPLAINANT REPORTED THAT THE DISTAL TIP OF THE AWL BROKE WHEN IT CONTACTED A SYSTEM IMPLANT CAGE AFTER THE INSERTER TIP BEING UTILIZED WAS DISENGAGED FROM THE IMPLANT. THE SYSTEM SURGICAL TECHNIQUE GUIDE PROVIDES GUIDANCE ON IMPLANT PLACEMENT UTILIZING THE INSERTER TIPS INCLUDED IN THE SURGICAL SYSTEM. IMPLANT SCREW HOLE PREPARATION IS PERFORMED WITH THE APPROPRIATE INSERTER TIP AND INSERTER ENGAGED WITH THE SYSTEM IMPLANT UNTIL SCREWS HAVE BEEN PLACED. THE ROOT CAUSE OF THIS COMPLAINT IS THE AWL WAS USED TO PREPARE PATIENT BONE WITHOUT AN INSERTER TIP ATTACHED TO THE INSERTER, WHICH ALLOWED THE AWL TO IMPACT THE IMPLANT CAGE. THERE NOT BEEN ANY OTHER COMPLAINTS OF SIMILAR NATURE FOR THIS INSTRUMENT IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THIS INSTRUMENT FOR COMPLAINTS FROM THE FIELD.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM INSTRUMENT MALFUNCTION ON (B)(6) 2022. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM AWL FRACTURED WHILE PREPARING PATIENT BONE FOR IMPLANT PLACEMENT DURING A PROCEDURE ON (B)(6) 2022. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT AWL WAS RECEIVED ON (B)(6) 2022 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521234 IRIX-C CERVICAL INTEGRATED FUSION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE OVE XTANT MEDICAL HOLDINGS, INC. T066-0205 EM14F003 M697T06602051

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other