BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 9504199 · Received December 20, 2019

    Report

    Report Number
    3025141-2019-00665
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    December 12, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ARTICLE: EXTRINSIC SUBCLAVIAN VEIN COMPRESSION AFTER OSTEOSYNTHESIS OF A MIDSHAFT CLAVICULAR FRACTURE IN AN ATHLETE; ROSSI, LUCIANO A.; PIUZZI, NICHOLAS S.; BONGIOVANNI, SANTIAGO L.; TANOIRA, IGNACIO; MAIGON, GASTON; RANALLETTA, MAXIMILIANO; CASE REPORTS IN ORTHOPEDICS, VOLUME 2015, ARTICLE ID 981293, 5 PAGES. CASE 1: PATIENT'S BROKEN CLAVICLE WAS TREATED BY IMPLANTING AN ACUMED LOCKING CLAVICLE PLATE. PATIENT EXPERIENCED A SUBCLAVIAN EXTERNAL COMPRESSION RELATED TO THE SECOND SCREW; PLATE AND SCREWS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296649 PLATE, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention