BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IO FIX

    MDR report key: 16482099 · Received March 3, 2023

    Report

    Report Number
    3007289093-2023-00003
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    January 10, 2023
    Report Date
    February 23, 2023
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K201556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN IMPLANT BROKE INTRAOPERATIVELY DUE TO OVER-TIGHTENING. A PORTION OF THE BROKEN IMPLANT REMAINED IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504016 IO FIX BONE SCREW HWC EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention