BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINEART DRILL

    MDR report key: 20309004 · Received September 26, 2024

    Report

    Report Number
    20309004
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 4, 2024
    Report Date
    September 5, 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 TIP BROKE OFF IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239703 SPINEART DRILL BIT, DRILL HTW SPINEART SA 4-7949

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female