BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLLIF TRAY FLEXIBLE HOOP CUTTER/DISC CUTTER

    MDR report key: 15044031 · Received July 15, 2022

    Report

    Report Number
    MW5110929
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    July 13, 2022
    Report Date
    July 14, 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 USING. ALL PIECES ACCOUNTED RETRIEVED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240354 OLLIF TRAY FLEXIBLE HOOP CUTTER/DISC CUTTER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ADVANCED RESEARCH MEDICAL LLC. 01-06-4REVA BD083AA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other