BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLLIF TRAY HOOP CUTTER/DISC CUTTER

    MDR report key: 13111093 · Received December 28, 2021

    Report

    Report Number
    MW5106317
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 22, 2021
    Report Date
    December 23, 2021
    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

    DISC CUTTER BROKE DURING USAGE. ALL PIECES WERE RETRIEVED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000117 OLLIF TRAY HOOP CUTTER/DISC CUTTER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ADVANCED RESEARCH MEDICAL LLC 01-06-4REVA BC130AA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Other