BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWER ORTHOPEDICS CORPORATION

    MDR report key: 11488671 · Received March 15, 2021

    Report

    Report Number
    3009996260-2021-00002
    Event Type
    Injury
    Date Received
    March 15, 2021
    Date of Event
    February 3, 2021
    Report Date
    March 15, 2021
    Manufacturer
    FLOWER ORTHOPEDICS
    Product Code
    HRS
    UDI-DI
    00840118111317
    PMA / PMN Number
    K131657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    THE EVENT INCLUDED THE FRACTURING OF AN IMPLANTED MTP PLATE AT THE COMPRESSION SLOT AFTER BEING IMPLANTED FOR 48 DAYS. THE AFFECTED HARDWARE WAS ABLE TO BE FULLY REMOVED.

    Description of Event or Problem · 1

    THE EVENT INCLUDED THE FRACTURING OF AN IMPLANTED MTP PLATE AT THE COMPRESSION SLOT AFTER BEING IMPLANTED FOR 60 DAYS. THE AFFECTED HARDWARE WAS ABLE TO BE FULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386750 FLOWER ORTHOPEDICS CORPORATION MTP PLATE HRS FLOWER ORTHOPEDICS MFP 402 2011321021 00840118111317

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention