BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRA HAMMERTOE CORRECTION SYSTEM

    MDR report key: 10367021 · Received August 5, 2020

    Report

    Report Number
    3009540749-2020-00021
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 9, 2020
    Report Date
    August 5, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    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.

    Description of Event or Problem · 1

    PATIENT HAD THREE NEXTRA HAMMERTOE CORRECTION SYSTEMS IMPLANTED ON AN UNKNOWN DATE AT THE 2ND TOE, 4TH TOE AND AN UNKNOWN TOE. AT AN UNKNOWN DATE, POST OP THE PATIENT REPORTED FEELING PAIN IN HIS 2ND TOE, AT WHICH POINT AN X-RAY WAS DONE AND REVEALED A PIECE OF THE IMPLANT BROKE AND WAS DISPLACED. ON (B)(6) 2020 THE SURGEON TRIED TO EXPLANT THE IMPLANT AT 2ND AND 4TH TOE. PRIOR TO ATTEMPTING TO REMOVE THE IMPLANT AT THE 2ND TOE, IT WAS NOTED THE INSERT SHOULDER OF THE PROXIMAL IMPLANT HAD BROKE INTO PIECES. WHEN THE SURGEON TRIED TO REMOVE THE IMPLANT AT THE 4TH TOE THE SHOULDER OF THE PROXIMAL IMPLANT BROKE IT PIECES. IT IS UNKNOWN WHY THE IMPLANT AT THE 4TH TOE WAS EXPLANTED. THE SURGEON WAS ABLE TO SUCCESSFULLY REMOVE THE MIDDLE IMPLANTS FROM THE 2ND AND 4TH TOE HOWEVER ALL THREE PROXIMAL IMPLANTS REMAIN IMPLANTED. THE SURGEON USED BONE PUTTY AND FUSED THE 2ND TOE WITH A K-WIRE AND THE 4TH TOE HE USED PUTTY AND AN EXTERNAL SPLINT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834835 NEXTRA HAMMERTOE CORRECTION SYSTEM BONE SCREW HWC NEXTREMITY SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR