BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 9495913 · Received December 19, 2019

    Report

    Report Number
    3025141-2019-00629
    Event Type
    Injury
    Date Received
    December 19, 2019
    Report Date
    December 6, 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: 3025141-2019-00626: CASE 1, 3025141-2019-00627: CASE 2, 3025141-2019-00628: CASE 3.

    Description of Event or Problem · 1

    ARTICLE: LOCKED ANATOMIC PLATE FIXATION IN DISPLACED CLAVICULAR FRACTURES; OZLER, TURHAN; GUVEN, MELIH; KOCADAL, ABDURRAHMAN ONUR; ULUCAY, CAGATAY; BEYZADEOGLU, TAHSIN; AND ALTINITAS, FAIK; ACTA ORTHOP TRAUMATOL TURC 2012; 46(4):237-242. CASE 4: PATIENT'S BROKEN CLAVICLE WAS TREATED BY IMPLANTING AN ACUMED LOCKING CLAVICLE PLATE. PATIENT EXPERIENCED IMPLANT FAILURE AFTER THE 3RD MONTH POST OP (LOSS OF REDUCTION AND LOOSE SCREWS); REVISION SURGERY TO REPLACE THE IMPLANT WITH A LONGER PLATE AND BONE GRAFT WAS PERFORMED AT THE 4TH MONTH POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293299 PLATE, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention