BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A.L.P.S. MVX

    MDR report key: 21049117 · Received December 31, 2024

    Report

    Report Number
    3012966183-2024-00026
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    December 5, 2024
    Report Date
    December 31, 2024
    Manufacturer
    TYBER MEDICAL
    Product Code
    HRS
    UDI-DI
    00196449015535
    PMA / PMN Number
    K232652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS INVESTIGATED WITHOUT THE AFFECTED DEVICE OR LOT INFORMATION. A DEVICE HISTORY RECORD REVIEW WAS NOT ABLE TO BE PERFORMED, AS NO LOT INFORMATION WAS PROVIDED. A DEVICE EVALUATION WAS NOT ABLE TO BE PERFORMED AS THE AFFECTED DEVICE WAS NOT AVAILABLE FOR RETURN AFTER EXPLANTATION. AN INTERVIEW WAS HELD WITH THE REPRESENTATIVE PRESENT IN THE SURGERY THAT REITERATED THE SURGEON DECIDED TO REVISE THE PLATE AFTER THE BONE FRAGMENT BROKE AS ONE POINT OF FIXATION PROXIMALLY WAS NOT ADEQUATE FOR THE FRACTURE TO HEAL. AT THE TIME OF THIS REPORT, THE ROOT CAUSE CANNOT BE DETERMINED WITH THE CURRENT INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    THE BONE FRAGMENT BROKE ON THE INTERFRAG SCREW AND THE SURGEON FELT THAT ONE POINT OF FIXATION PROXIMALLY WAS NOT ADEQUATE FOR THIS TO HEAL SO WE OPTED TO REVISE THE PLATE AND PUT ON A DIFFERENT PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090590 A.L.P.S. MVX ANATOMIC LAT FIB PLATE 4H RT HRS TYBER MEDICAL 770708042 00196449015535

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other