BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 9504177 · Received December 20, 2019

    Report

    Report Number
    3025141-2019-00658
    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

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00650: CASE 1, 3025141-2019-00651: CASE 2, 3025141-2019-00652: CASE 3, 3025141-2019-00653: CASE 4, 3025141-2019-00654: CASE 5, 3025141-2019-00655: CASE 6, 3025141-2019-00656: CASE 7, 3025141-2019-00657: CASE 8, 3025141-2019-00659: CASE 10, 3025141-2019-00660: CASE 11, 3025141-2019-00661: CASE 12, 3025141-2019-00662: CASE 13, 3025141-2019-00663: CASE 14, 3025141-2019-00664: CASE 15.

    Description of Event or Problem · 1

    ARTICLE: COMPLICATIONS ASSOCIATED WITH PLATE FIXATION OF ACUTE MIDSHAFT CLAVICLE FRACTURES VERSUS NON-UNIONS"; SAWALHA, SEIF; GUISASOLA, INIGO; EUROPEAN JOURNAL OF ORTHOPEDIC SURGERY & TRAUMATOLOGY (2018) 28:1059-1064. PATIENT'S BROKEN CLAVICLE WAS TREATED BY IMPLANTING AN ACUMED LOCKING CLAVICLE PLATE. PATIENT EXPERIENCED EARLY FIXATION FAILURE REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296325 PLATE, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention