BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSS PLATE MTP, RIGHT ANCHORAGE

    MDR report key: 20797368 · Received November 27, 2024

    Report

    Report Number
    0008031020-2024-00631
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    January 1, 2024
    Report Date
    November 27, 2024
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. (REGISTERED UNDER 510(K)# K083447). THEREFORE, IT IS SUBJECT TO REPORTABILITY UNDER MDR. BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "THE HOSPITAL INFORMED ME THEY HAD THE SAME PLATE REMOVED FROM A PATIENT EARLIER IN THE YEAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367366 CROSS PLATE MTP, RIGHT ANCHORAGE PLATE, FIXATION, BONE HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention