BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOMED PERIOSTEAL ELEVATOR

    MDR report key: 8260840 · Received January 17, 2019

    Report

    Report Number
    MW5083220
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    January 15, 2019
    Report Date
    January 16, 2019
    Manufacturer
    INNOMED ORTHOPEDIC INSTRUMENTS / INNOMED, INC.
    Product Code
    EML
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT IN SURGERY FOR TOTAL HIP ARTHROPLASTY. A PERIOSTEAL ELEVATOR (CHISEL TYPE PRODUCT) #3450, BEING UTILIZED BY THE SURGEON BROKE. ALL PIECES RETRIEVED. NO HARM TO THE PATIENT. REFERRED TO MANAGER OF CENTRAL STERILE TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52328 INNOMED PERIOSTEAL ELEVATOR CHISEL EML INNOMED ORTHOPEDIC INSTRUMENTS / INNOMED, INC. 3450

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR