BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST DRILL

    MDR report key: 4648208 · Received March 27, 2015

    Report

    Report Number
    9610905-2015-00018
    Event Type
    Injury
    Date Received
    March 27, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 25, 2015
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO KG Q
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, THE TWIST DRILL BROKE OFF IN THE PT'S MANDIBLE. SURGERY WAS DELAYED TO PERFORM AN X-RAY, WHICH REVEALED THE BROKEN PORTION STILL RESIDING IN THE PT'S BONE. DOCTOR DECIDED TO LEAVE THE BROKEN PORTION WITHIN THE PT'S MANDIBLE AND NO PERFORM A SECOND SURGERY FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205502 TWIST DRILL TWIST DRILL HTW KARL LEIBINGER MEDIZINTECHNIK GMBH & CO KG Q 25-458-19-07

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other