BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTEX SPINAL FIXATION SYSTEM

    MDR report key: 7622700 · Received June 20, 2018

    Report

    Report Number
    3005031160-2018-00018
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    HXX
    UDI-DI
    M697X06704251
    PMA / PMN Number
    K160428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED THAT TWO CROSS CONNECTOR LOCKING DRIVERS WERE BROKEN AND REQUESTED TO RETURN THE BROKEN PARTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO KNOWN PATIENT COMPLICATIONS. ATTEMPTS TO COLLECT COMPLAINT DETAILS WERE MADE ON 05/24/2018, 05/29/2018, 06/04/2018, 06/12/2018, 06/13/2018, 06/14/2015, AND 06/15/2018. THE COMPLAINANT WAS UNABLE TO PROVIDE SUFFICIENT DETAILS TO THOROUGHLY INVESTIGATE THE COMPLAINT ISSUE. DEVICES FROM LOT NUMBERS 041044, AND 054649 WERE RETURNED TO THE COMPANY BY THE COMPLAINANT ON 05/29/2018. A VISUAL ASSESSMENT WAS PERFORMED, AND THE CORRESPONDING DHRS WERE REVIEWED. NO MANUFACTURING ANOMALIES WERE IDENTIFIED DURING THE DHR REVIEWS AND THE PARTS MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT TWO CROSS CONNECTOR LOCKING DRIVERS WERE BROKEN AND REQUESTED TO RETURN THE BROKEN PARTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462514 CERTEX SPINAL FIXATION SYSTEM SPINAL IMPLANTS HXX X-SPINE SYSTEMS, INC. X067-0425 041044, 054649 M697X06704251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other