BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGNX

    MDR report key: 11991954 · Received June 14, 2021

    Report

    Report Number
    3007289093-2021-00008
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 14, 2021
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HRS
    PMA / PMN Number
    K181067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NON-HEALING FUSION SITE, HARDWARE REMOVED FOR MORE EXTENSIVE FUSION HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886644 ALIGNX BONE PLATE HRS EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention