BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO BURS

    MDR report key: 7689437 · Received July 16, 2018

    Report

    Report Number
    7689437
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    May 30, 2018
    Report Date
    July 10, 2018
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE LEFT TOTAL KNEE ARTHROPLASTY A 4.0 MM STANDARD BUR REF#(B)(4) BROKE. THE BROKEN BURR WAS SEQUESTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532747 MICRO BURS SURGICAL BURR GFF BRASSELER U.S.A. MEDICAL, LLC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31025 DA