BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE LOOP CUTTER

    MDR report key: 17479762 · Received August 7, 2023

    Report

    Report Number
    MW5120705
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Report Date
    August 3, 2023
    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

    BROKE INTO TWO PIECES WHILE USING. ALL PIECES RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099449 FLEXIBLE LOOP CUTTER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ADVANCED RESEARCH MEDICAL, LLC. 01-06-4 REV A BE037AA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other