BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRA HAMMERTOE CORRECTION SYSTEM

    MDR report key: 10349372 · Received July 31, 2020

    Report

    Report Number
    3009540749-2020-00018
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Report Date
    July 31, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K110445
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS FOR THE PRODUCT WERE REVIEWED AND REVEAL NO MANUFACTURING DEFECTS. THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR REVIEW. ROOT CAUSE IS UNKNOWN WITH THE INFORMATION REPORTED. IF ADDITIONAL INFORMATION IS OBTAINED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A NEXTRA HAMMERTOE CORRECTION IMPLANT PROCEDURE ON (B)(6) 2020. AT THE 2 WEEK POST OP THE PROXIMAL AND MIDDLE IMPLANTS WERE NO LONGER CONNECTED, THE SURGEON SIMPLY RECONNECTED THE IMPLANTS, HOWEVER IT WAS REPORTED THAT THEY BECAME SEPARATED THE NEXT DAY. THERE WAS NOT FURTHER ACTION NOTED AND THE IMPLANTS REMAIN IMPLANTED. NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817013 NEXTRA HAMMERTOE CORRECTION SYSTEM BONE SCREW HWC NEXTREMITY SOLUTIONS 168228317B

    Patients

    Seq Age Sex Outcome Treatment
    1