BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXLE INTERSPINOUS FUSION SYSTEM

    MDR report key: 14029759 · Received April 6, 2022

    Report

    Report Number
    3005031160-2022-00016
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 8, 2022
    Report Date
    April 6, 2022
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    PEK
    UDI-DI
    M697X06015201
    PMA / PMN Number
    K130438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT OF THE RETURNED COMPLAINT INSERTER/COMPRESSOR SHOWED AND INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY SURFACE SCRATCHES AND IMPLANT ENGAGEMENT INTERFACE WEAR MARKS. THE PIN OF THE INSTRUMENT DISTAL TIP WAS FRACTURED WHERE IT CONNECTS WITH THE INSTRUMENT HANDLE. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED INSERTER/COMPRESSOR, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. IT MAY BE POSSIBLE THAT APPLICATION OF EXCESSIVE COMPRESSION FORCE MAY HAVE CONTRIBUTED TO THE INSTRUMENT'S DISTAL TIP FRACTURING FROM THE DEVICE. THIS CAN BE EXACERBATED BY PLACEMENT OF THE IMPLANT TOO FAR ANTERIOR, WHICH IS WHERE THE ANATOMY SLOPES. THIS CAN CAUSE THE INSTRUMENT TO SEE INCREASED TRANSVERSE FORCES ON THE PIN, AS WELL AS A BENDING MOMENT INTRODUCED BY THE IMPLANT TRYING TO REST AGAINST THE ANATOMY. THERE HAS BEEN ONE OTHER COMPLAINT 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 ON 3/08/2022 OF A SYSTEM INSERTER/COMPRESSOR THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT ONE OF THE DISTAL TIPS OF THE INSTRUMENT FRACTURED WHILE COMPRESSING INTERSPINOUS PLATES INTO PLACE AND SECURING THE PLATES. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE AVAILABLE INSTRUMENT. THE COMPLAINT INSTRUMENT ARRIVED AT THE MANUFACTURER FOR ASSESSMENT ON 3/10/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825019 AXLE INTERSPINOUS FUSION SYSTEM SPINOUS PROCESS PLATE PEK XTANT MEDICAL HOLDINGS, INC. X060-1520 21179 M697X06015201

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other