BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBLIQUE LATERAL LUMBAR INTERBODY FUSION SYSTEM: LUMBAR IBFD - OLLIF

    MDR report key: 12188804 · Received July 16, 2021

    Report

    Report Number
    MW5102611
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Report Date
    July 14, 2021
    Manufacturer
    ADVANCED RESEARCH MEDICAL LLC
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING DISC CUTTER (FLEXIBLE CURETTE) BROKE. BOTH PIECES RETRIEVED, NO PATIENT HARM. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082276 OBLIQUE LATERAL LUMBAR INTERBODY FUSION SYSTEM: LUMBAR IBFD - OLLIF DISC CUTTER MAX ADVANCED RESEARCH MEDICAL LLC BB350AA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other