BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM FIF STEM TYPE A 14/10

    MDR report key: 20253115 · Received September 18, 2024

    Report

    Report Number
    3014545273-2024-00002
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 13, 2024
    Manufacturer
    OSSEOINTEGRATION INTERNATIONAL INC.
    Product Code
    PJY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD A STEM IMPLANTED ON (B)(6) 2022. THE PATIENT'S SURGEON NOTED THAT THE PATIENT HAD BEEN "PULLED" BY THEIR HORSE WHICH CAUSED AN AUDIBLE "POP" SOUND. FOLLOWING THIS, THE PATIENT NOTICED THAT THE DEVICE WAS ROTATING AND X-RAY WAS TAKEN ON (B)(6) 2024 WHICH DID NOT INDICATE ANY BREAKAGE. ON (B)(6) 2024, THE DISTAL END OF THE PATIENT'S IMPLANT BROKE WHILE THEY WERE WALKING. THE PATIENT HAS NOT REPORTED ANY PAIN OR FURTHER HARM AS A RESULT OF THE BREAKAGE. A ONE-STAGE REVISION PROCEDURE IS SCHEDULED TO REPLACE THE PATIENT'S BROKEN IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532038 CUSTOM FIF STEM TYPE A 14/10 PJY OSSEOINTEGRATION INTERNATIONAL INC. COPL1-14140

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention