BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, ELBOW, HEMI-, RADIAL

    MDR report key: 8492757 · Received April 8, 2019

    Report

    Report Number
    3025141-2019-00199
    Event Type
    Injury
    Date Received
    April 8, 2019
    Report Date
    March 13, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    KWI
    PMA / PMN Number
    K131845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ARTICLE: OUTCOMES FOLLOWING SURGICAL MANAGEMENT OF COMPLEX TERRIBLE TRIAD INJURIES OF THE ELBOW: A SINGLE SURGEON CASE SERIES. DOMOS, PETER, GRIFFITHS, EMMET, WHITE, ANDREW. SOULDER & ELBOW 2018, VOL. 10(3) 216-222. CASE 1: REMOVAL OF ARH IMPLANT TO IMPROVE PATIENT RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284753 PROSTHESIS, ELBOW, HEMI-, RADIAL KWI ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention