BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX

    MDR report key: 11923440 · Received June 2, 2021

    Report

    Report Number
    3007289093-2021-00006
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    March 25, 2021
    Report Date
    June 2, 2021
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K130120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN APEX CONSTRUCT WAS REMOVED DUE TO A NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814903 APEX BONE SCREW HWC EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention