BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KLS PLATES

    MDR report key: 7321340 · Received February 28, 2018

    Report

    Report Number
    7321340
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    November 27, 2017
    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 RIB FRACTURES ON THE RIGHT SIDE HAD SURGERY ON (B)(6) 2017 - RIGHT VATS, RIGHT 9TH AND 10TH RIB PLATING. THIS WAS A TRIAL OF KLS PLATES BY DR. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2017 FOR REMOVAL OF BROKEN RIB PLATES AND REPLACEMENT OF NEW RIB PLATES RIGHT 9 AND 10 RIBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148632 KLS PLATES PLATES HRS KLS MARTIN GROUP 33164231

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization