BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRA HAMMERTOE CORRECTION SYSTEM

    MDR report key: 10968338 · Received December 8, 2020

    Report

    Report Number
    3009540749-2020-00044
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 11, 2020
    Report Date
    December 8, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K110445
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDED RELATED TO THE EVENT WERE REVIEWED. THERE WERE NO NON-CONFORMANCES 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 SURGERY THAT TOOK PLACE ON (B)(6) 2020 THE SURGEON HAD DIFFICULTIES MATING THE NEXTRA DRIVER WITH THE PROXIMAL IMPLANT. NO ADDITIONAL INFORMATION OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435841 NEXTRA HAMMERTOE CORRECTION SYSTEM SCREW HWC NEXTREMITY SOLUTIONS 168125017B

    Patients

    Seq Age Sex Outcome Treatment
    1