BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOHORIZONS DRILL EXTENDER

    MDR report key: 1874241 · Received October 8, 2010

    Report

    Report Number
    1060818-2010-00004
    Event Type
    Other
    Date Received
    October 8, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS, INC.
    Product Code
    DZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EXAMINATION OF THE RETURNED DEVICE, THE INVESTIGATOR NOTED FRACTURE OF THE CASING AND CORROSION DAMAGE, IN ADDITION TO YIELDING OF THE ISO 1797-1 LATCH. THE INVESTIGATOR CONCLUDED THAT THE CORROSION DAMAGE AND FRACTURE AT THE INTERFERENCE CONNECTION INDICATED THE DEVICE HAD SEEN EXTENDED USE, AND THAT THE USER LIKELY OVERLOADED AND/OR IMPROPERLY CLEANED THE DEVICE. NO MANUFACTURING NONCONFORMITIES WERE NOTED.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE DRILL EXTENDER CRACKED WHERE THE DRILL MEETS THE HOUSING. THE CLINICIAN HAD TO TERMINATE THE PROCEDURE UNTIL A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOHORIZONS DRILL EXTENDER DENTAL DRILL EXTENDER DZA BIOHORIZONS IMPLANT SYSTEMS, INC. 122-100 PO08000122

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other