BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRA HAMMERTOE CORRECTION SYSTEM

    MDR report key: 10554068 · Received September 18, 2020

    Report

    Report Number
    3009540749-2020-00031
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Report Date
    September 18, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K110445
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS RELATED TO THE EVENT WERE REVIEWED. THERE WERE NO NON-CONFORMANCE'S DETECTED THROUGH THE DEVICE HISTORY RECORD REVIEW. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE.

    Description of Event or Problem · 1

    DURING A NEXTRA HAMMERTOE CORRECTION SURGERY THAT OCCURED ON AN UNKNOWN DATE, THE SURGEON REPORTED HAVING DIFFICULTY CONNECTING AND PROXIMAL END OF THE DRIVER WITH THE PROXIMAL IMPLANT. THE SURGEON WAS ABLE TO GET ENOUGH OF THE IMPLANT ON THE DRIVER TO COMPLETE THE SURGERY, BUT THEN HAD DIFFICULTY REMOVING THE DRIVER FROM THE IMPLANT. THE PATIENT WAS REPORTED AS HAVING VERY OSTEOPENIC BONE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018230 NEXTRA HAMMERTOE CORRECTION SYSTEM BONE SCREW HWC NEXTREMITY SOLUTIONS 168125017B

    Patients

    Seq Age Sex Outcome Treatment
    1