BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE CURRETTE BLADE DISC CUTTER OR HOOP CUTTER

    MDR report key: 13798203 · Received March 16, 2022

    Report

    Report Number
    MW5108211
    Event Type
    Malfunction
    Date Received
    March 16, 2022
    Date of Event
    March 9, 2022
    Report Date
    March 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

    BLADE HOOP CUTTER/DISC CUTTER BROKE DURING USE. ALL PIECES ACCOUNTED FOR. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525837 FLEXIBLE CURRETTE BLADE DISC CUTTER OR HOOP CUTTER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ADVANCED RESEARCH MEDICAL LLC 01-06-4 REVA BC130AA-2

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other