BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 9489878 · Received December 18, 2019

    Report

    Report Number
    3025141-2019-00611
    Event Type
    Injury
    Date Received
    December 18, 2019
    Report Date
    November 27, 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: MECHANICAL FAILURE OF PLATE BREAKAGE AFTER OPEN REDUCTION AND PLATE FIXATION OF DISPLACED MIDSHAFT CLAVICLE FRACTURE - A POSSIBLE NEW RISK FACTOR: A CASE REPORT; BATASH, RON; DEBI, RONEN; GRINBERG, DAN; SHEMA, MAAYAN; ELBAZ, AVI; BENEDICT, YESHALAU; JOURNAL OF MEDICAL CASE REPORTS; (2109) 13:127. CASE 1: PATIENT'S BROKEN CLAVICLE WAS PLATED WITH AN ACUMED LOCKING CLAVICLE PLATE. FIVE WEEKS POST OP, THE PLATE BROKE. IT WAS EXPLANTED AND A NEW LONGER PLATE IMPLANTED, ALONG WITH A BONE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284435 PLATE, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention