BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMA SYSTEM

    MDR report key: 8573904 · Received May 1, 2019

    Report

    Report Number
    MW5086341
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    November 21, 2018
    Report Date
    May 1, 2019
    Manufacturer
    PANTHER ORTHOPEDICS, INC.
    Product Code
    HTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED TO REPORT AN ADVERSE EVENT INVOLVING HER PUMA SYSTEM DEVICE, WHICH WAS IMPLANTED ON (B)(6) 2018. PATIENT STATED THAT THE DEVICE WORKED WELL FOR HER AND HELPED HER HEAL APPROPRIATELY, HOWEVER, SHE SAW ON X-RAY THAT THE DEVICE WAS FRACTURED. PATIENT STATED THAT HER PHYSICIAN DECIDED TO LEAVE THE BROKEN DEVICE IMPLANTED IN HER. PATIENT STATES SHE FELT IT WAS IMPORTANT TO MAKE FDA AWARE OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361335 PUMA SYSTEM WASHER, BOLT, NUT HTN PANTHER ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR