BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COFLEX INTERLAMINAR TECHNOLOGY

    MDR report key: 17410015 · Received July 27, 2023

    Report

    Report Number
    3005031160-2023-00013
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    June 27, 2023
    Report Date
    July 27, 2023
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    HXL
    UDI-DI
    04260148890130
    PMA / PMN Number
    P110008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL AND FUNCTIONAL ASSESSMENTS COULD NOT BE PERFORMED DUE TO THE COMPLAINT INSTRUMENT NOT BEING RETURNED FOR ASSESSMENT. A DHR REVIEW COULD NOT BE PERFORMED DUE TO THE LOT NUMBER OF THE COMPLAINT INSTRUMENT NOT BEING AVAILABLE. THE AGE OF THE COMPLAINT INSTRUMENT COULD NOT BE IDENTIFIED. THE HEAD OF THE SYSTEM MALLET IS SECURED INTO THE HANDLE WITH AN EPOXY GLUE. IT MAY BE POSSIBLE THAT REPEATED USE AND EXPOSURE TO STERILIZATION CYCLES MAY HAVE CONTRIBUTED TO THE GLUE NOT MAINTAINING ADHESION AS INTENDED. REPEATED IMPACTS TO THE MALLET AS WELL AS EXPOSURE TO STERILIZATION CYCLES MAY HAVE CONTRIBUTED TO THE REPORTED INSTRUMENT MALFUNCTION. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE RELIABLY DETERMINED. THERE HAVE NOT BEEN ANY 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 WAS MADE AWARE OF AN INSTRUMENT MALFUNCTION ON 6/27/2023. IT WAS REPORTED THAT THE HEAD OF A SYSTEM MALLET FRACTURED FROM THE HANDLE OF AN INSTRUMENT WHILE BEING USED DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT, AN ALTERNATE AVAILABLE MALLET FROM THE SURGICAL FACILITY WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. EMAIL INQUIRIES WERE SENT TO THE COMPLAINANT FOR ADDITIONAL COMPLAINT INCIDENT INFORMATION AND RETURN OF THE COMPLAINT INSTRUMENT, WHICH WERE UNSUCCESSFUL. AN RMA NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH AS OF 7/26/2023 HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223106 COFLEX INTERLAMINAR TECHNOLOGY PROSTHESIS, SPINOUS PROCESS SPACER/PLATE HXL XTANT MEDICAL HOLDINGS, INC. UAT20100 04260148890130

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown