BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOHORIZONS ONE-PIECE HEX DRIVER

    MDR report key: 3131142 · Received May 23, 2013

    Report

    Report Number
    1060818-2013-00002
    Event Type
    Other
    Date Received
    May 23, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BIOHORIZONS
    Product Code
    DZA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED BY THE CLINICIAN FOR EVAL. THE ADVERSE EVENT IS ATTRIBUTED TO THE CLINICIAN NOT USING A DENTAL DAM WHILE USING THE HEX DRIVER IN THE SURGICAL PROCEDURE. BECAUSE THE HEX DRIVER IS A HAND INSTRUMENT, THE DEVICE IS IMPLICATED ONLY DUE TO ITS USAGE IN THE PROCEDURE.

    Description of Event or Problem · 1

    A ONE-PIECE, LONG HEX DRIVER (135-451) WAS USED DURING A SURGICAL PROCEDURE FOR PLACING A DENTAL IMPLANT. IN THE MIDDLE OF THE PROCEDURE, THE PT SWALLOWED THE 135-451. THE 135-451 IS A HANDHELD INSTRUMENT USED BY CLINICIANS TO INSTALL OR REMOVE COVER SCREWS, HEALING ABUTMENTS AND/OR ABUTMENT SCREWS. A DENTAL DAM WAS NOT USED BY THE CLINICIAN DURING THE PROCEDURE. TWO DAYS AFTER THE EVENT, THE CLINICIAN FOLLOWED UP WITH THE PT AND ADVISED THE PT TO RECEIVE A SCAN SINCE THE PT HAD NOT PASSED THE HEX DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228204 BIOHORIZONS ONE-PIECE HEX DRIVER ONE-PIECE DENTAL HEX DRIVER DZA BIOHORIZONS 135-451 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other