BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 9483436 · Received December 17, 2019

    Report

    Report Number
    3025141-2019-00606
    Event Type
    Injury
    Date Received
    December 17, 2019
    Report Date
    November 25, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00607: CASE 2.

    Description of Event or Problem · 1

    ARTICLE: THE CLAVICLE TRIAL - A MULTICENTER RANDOMIZED CONTROLLED TRIAL COMPARING OPERATIVE WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICLE FRACTURES; AHRENS, PHILIP M., FRCS; GARLICK, NICHOLAS I., FRCS; BARBER, JULIE, PHD; TIMS, EMILY M., MSC AND THE CLAVICLE COLLABORATIVE; J BONE SURG AM. 2017; 99:1345-54 . CASE 1: PATIENT EXPERIENCED SURGICAL FAILURE FOLLOWING IMPLANTATION OF AN ACUMED CLAVICLE PLATE; THE PATIENT UNDERWENT REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272220 PLATE, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention