BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ACUTRAK

    MDR report key: 96968 · Received June 4, 1997

    Report

    Report Number
    3025141-1997-00004
    Event Type
    Injury
    Date Received
    June 4, 1997
    Date of Event
    May 7, 1997
    Report Date
    June 3, 1997
    Manufacturer
    ACUMED, INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE DRILLING TO 24MM, AT 10-12MM, THE SURGEON HEARD THE DRILL TIP SNAP. THE SURGEON ATTEMPTED TO RETRIEVE THE TIP. ULTIMATELY, THE TIP WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI ACUTRAK DRILL HTW ACUMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other