BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALLUX

    MDR report key: 9749723 · Received February 25, 2020

    Report

    Report Number
    3007289093-2020-00006
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    January 6, 2020
    Report Date
    February 25, 2020
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K091577
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED A NON-UNION AFTER HALLUX LAG SCREW BREAKAGE. DEVICE WAS ORIGINALLY IMPLANTED APPROXIMATELY 10 YEARS PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214880 HALLUX BONE SCREW HWC EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention