BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZON DENTAL IMPLANT DRILL

    MDR report key: 3111279 · Received May 9, 2013

    Report

    Report Number
    1060818-2013-00001
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BIOHORIZONS
    Product Code
    DZA
    PMA / PMN Number
    K060267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE MFR'S EVAL, THE DRILL EXTENDER WAS TESTED ON AN INTERFACE VERIFICATION TEST (IVT) WITH A MATING (B)(4) SHANK. THE INVESTIGATOR CONCLUDED THE DRILL EXTENDER DID NOT WORK PROPERLY. THE FREQUENCY OF USAGE COULD NOT BE DETERMINED OR ASCERTAINED. THE DRILL EXTENDER'S (B)(4) SHANK SLIPS OUT EASILY WHEN THE DRILL EXTENDER IS POINTED DOWNWARD. THIS DRILL EXTENDER WAS PURCHASED IN (B)(4) 2011 AS PART OF A SURGICAL KIT.

    Description of Event or Problem · 1

    IN THE COURSE OF THE SURGICAL PROCEDURE FOR IMPLANTING AN IMPLANT, A STARTER DRILL WAS BEING USED WITH A DRILL EXTENDER (122-100). DURING THE PROCEDURE, THE CLINICIAN FAILED TO USE A DENTAL DAM. THE STARTER DRILL FELL OUT OF THE EXTENDER AND THE PT SWALLOWED THE DRILL. THE PT WAS TAKEN TO THE EMERGENCY ROOM (ER) THE SAME DAY. THE ER PERSONNEL EXTRACTED THE STARTER DRILL AND THE PT WAS RELEASED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204771 BIOHORIZON DENTAL IMPLANT DRILL DENTAL IMPLANT DRILL DZA BIOHORIZONS 122-100 PO11031341A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention