BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL TWIST 5" X 2.0 MM FLUTE

    MDR report key: 9645095 · Received January 29, 2020

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    Report

    Report Number
    2249529-2019-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    October 16, 2019
    Report Date
    October 24, 2019
    Manufacturer
    GSOURCE, LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    REF: (B)(4). REF: REPORT#MW5090644.

    Description of Event or Problem · 1

    REFER TO UF REPORT# MW5090644.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108292 DRILL TWIST 5" X 2.0 MM FLUTE DRILL BIT HTW GSOURCE, LLC GS 86.8420 1805

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR