BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KLS PLATES

    MDR report key: 7321342 · Received February 28, 2018

    Report

    Report Number
    7321342
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    January 15, 2018
    Report Date
    February 19, 2018
    Manufacturer
    KLS MARTIN GROUP
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH CLOSED FRACTURE OF RIB HAD A LEFT THORACOSCOPY VIDEO ASSISTED VATS, PLATING 6TH AND 7TH RIB ON (B)(6) 2017. THIS WAS PART OF A REQUESTED TRIAL OF KLS PLATES BY DR. DUE TO NON UNION, THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2018 FOR LEFT THORACOSCOPY VIDEO ASSISTED VATS, RIB PLATE HARDWARE REMOVAL X 2 RIBS, RIB PLATING X 2 RIBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148646 KLS PLATES PLATES HRS KLS MARTIN GROUP 33209098

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization