BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINEART DRILL BIT

    MDR report key: 20504639 · Received October 22, 2024

    Report

    Report Number
    20504639
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 24, 2024
    Report Date
    September 30, 2024
    Manufacturer
    SPINEART SA
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DRILL BIT BROKE OFF IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006322 SPINEART DRILL BIT BIT, DRILL HTW SPINEART SA 4-7949

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose