BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERIOR MIDSHAFT PLATE, RT, 8-HOLE

    MDR report key: 10880311 · Received November 20, 2020

    Report

    Report Number
    2031009-2020-00005
    Event Type
    Injury
    Date Received
    November 20, 2020
    Date of Event
    October 22, 2020
    Report Date
    April 20, 2021
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    UDI-DI
    00842188100369
    PMA / PMN Number
    K112509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    AFTER THE INITIAL REPORT WAS SUBMITTED THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS DETERMINED THAT THE DEVICE MET TRIMED'S PRODUCT SPECIFICATIONS. IT WAS ALSO DETERMINED THAT THE CAUSE OF THE NONUNION WAS DUE TO THE PATIENT BEING A HEAVY SMOKER.

    Description of Event or Problem · 1

    A TRIMED SALES REP LOCATED IN (B)(6) REPORTED ON 22 OCT 2020 THAT A PLATE (CPSMIDR-8) HAD TO BE REMOVED FROM A PATIENT BECAUSE OF A NONUNION. THE PLATE WAS ORIGINALLY IMPLANTED ON (B)(6) 2020, AND THE PATIENT STARTED BEGIN FEELING DISCOMFORT ON (B)(6) 2020. IT WAS DETERMINED ON (B)(6) 2020 THAT THE PLATE WOULD NEED TO BE REMOVED DUE TO THE NONUNION. IT WAS STATED THAT THE PATIENT WAS A HEAVY SMOKER AND NOT FOLLOWING PROPER AFTER CARE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345133 SUPERIOR MIDSHAFT PLATE, RT, 8-HOLE SUPERIOR MIDSHAFT PLATE, RT, 8-HOLE HRS TRIMED, INC. CPSMIDR-8 SY9164 00842188100369

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention