BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRA HAMMERTOE CORRECTION SYSTEM

    MDR report key: 10657943 · Received October 9, 2020

    Report

    Report Number
    3009540749-2020-00035
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    August 12, 2020
    Report Date
    October 9, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K1100445
    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. 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 ONE OF THE NEXTRA HAMMERTOE CORRECTION SYSTEM COMPONENTS FAILED. NO ADDITIONAL INFORMATION PROVIDED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121471 NEXTRA HAMMERTOE CORRECTION SYSTEM BONE SCREW HWC NEXTREMITY SOLUTIONS 168228317B

    Patients

    Seq Age Sex Outcome Treatment
    1