BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIGATED PEDICLE ACCESS KIT

    MDR report key: 17868417 · Received October 3, 2023

    Report

    Report Number
    MW5146484
    Event Type
    Injury
    Date Received
    October 3, 2023
    Report Date
    September 29, 2023
    Manufacturer
    IZI MEDICAL PRODUCTS LLC
    Product Code
    OLO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: BECAUSE THE NEEDLES BEND AS SOON AS THE FIRST MALLET IS STRUCK (ESPECIALLY THE OUTER SHEATH). BRAND ILUMARK REF MP6001 (B)(6) DISPOSABLE PASSIVE ARRAY - PEDICLE ACCESS KIT COMPATIBLE. USE OF SINGLE-USE EQUIPMENT HIGH COST FOR THE HOSPITAL. LOSS OF TIME FOR THE CARE TEAM. LOSS OF CHANCE FOR THE PATIENT, WHO HAS TO BE PUT TO SLEEP FOR LONGER. ECOLOGICAL PROBLEM. CONSEQUENCE : USE OF ANOTHER KIT. REFERENCE REPORT: MW5146483. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342750 NAVIGATED PEDICLE ACCESS KIT ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO IZI MEDICAL PRODUCTS LLC MP6001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NAVIGATION MARKER, REFLECTIVE MARKER SPHERES.