BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRA HAMMERTOE CORRECTION SYSTEM

    MDR report key: 11309456 · Received February 10, 2021

    Report

    Report Number
    3009540749-2020-00004
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Report Date
    February 9, 2021
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    UDI-DI
    00817701020059
    PMA / PMN Number
    K110445
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS REPORT WAS ORIGINALLY SUBMITTED JAN 10TH 2020 WITH A TYPO IN THE MFR REPORT NUMBER WHICH RESULTED IN A DUPLICATE MFR REPORT NUMBER. IT WAS NOTED ON A LATER DATE BY NEXTREMITY SOLUTIONS THAT RECORD OF 3009540749-2020-00004 WAS NOT IN MAUDE. THIS REPORT IS BEING SUBMITTED WITH THE MFR REPORT NUMBER CORRECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY WITH THE NEXTRA HAMMERTOE CORRECTION SYSTEM, THE PROXIMAL AND MIDDLE IMPLANTS DID NOT SIT FLUSH ON THE NEXTRA DRIVER. THIS CONDITION DID NOT AFFECT THE SURGERY. THE SURGERY WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202617 NEXTRA HAMMERTOE CORRECTION SYSTEM BONE SCREW HWC NEXTREMITY SOLUTIONS NX-3532K-SC 168125017B 00817701020059

    Patients

    Seq Age Sex Outcome Treatment
    1