BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE HOOP CUTTER/DISC CUTTER

    MDR report key: 14677379 · Received June 10, 2022

    Report

    Report Number
    MW5110288
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    June 7, 2022
    Report Date
    June 9, 2022
    Manufacturer
    ADVANCED RESEARCH MEDICAL, LLC
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRODUCT BROKE WHILE REMOVING DISC. ALL PIECES COLLECTED. OLLIF TRAY. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2814403 FLEXIBLE HOOP CUTTER/DISC CUTTER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ADVANCED RESEARCH MEDICAL, LLC 01-06-4REVA BC274AA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other