BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXLE INTERSPINOUS FUSION SYSTEM

    MDR report key: 14292741 · Received May 5, 2022

    Report

    Report Number
    3005031160-2022-00019
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 4, 2022
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    PEK
    UDI-DI
    M697X06003201
    PMA / PMN Number
    K130438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT OF THE RETURNED COMPLAINT SCREWDRIVER SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY WORN LASER MARKINGS, SURFACE SCRATCHES, AND WORN TIN COATING AT THE DISTAL TIP. THE DISTAL TIP OF THE RETURNED COMPLAINT SCREWDRIVER WAS FRACTURED AND TWISTED IN A MANNER THAT INDICATES IT WAS BEING ROTATED CLOCKWISE WHEN THE INSTRUMENT MALFUNCTION OCCURRED. 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 SCREWDRIVER 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 2/25/2013. IT MAY BE POSSIBLE FOR THE DISTAL TIP OF THE SYSTEM SCREWDRIVER TO FRACTURE IF IT WAS SHIFTED OUT OF ALIGNMENT WITH A SYSTEM SCREW WHILE ENGAGED, OR IF IT WAS ROTATED WHILE NOT FULLY SEATED IN THE HEAD OF A SYSTEM SCREW. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE RELIABLY DETERMINED. THERE HAVE BEEN FIVE OTHER COMPLAINTS OF SIMILAR NATURE 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 SCREWDRIVER MALFUNCTION ON (B)(6) 2022. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHILE FINAL TIGHTENING AN IMPLANT DURING A PROCEDURE ON (B)(6) 2022. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 4/22/2022 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177494 AXLE INTERSPINOUS FUSION SYSTEM SPINOUS PROCESS PLATE PEK XTANT MEDICAL HOLDINGS, INC. X060-0320 041618 M697X06003201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other