BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZON DENTAL IMPLANT DRILL

    MDR report key: 2875130 · Received December 12, 2012

    Report

    Report Number
    1060818-2012-00001
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    BIOHORIZONS
    Product Code
    DZE
    PMA / PMN Number
    K060267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE MANUFACTURER EVALUATION, THE INVESTIGATOR CONCLUDED: ...THE ADVERSE CLINICAL SCENARIO THAT COULD HAVE CAUSED EXCESSIVE LOADING IS NOT READILY IDENTIFIABLE. HOWEVER, THE MARKING ON THE DRILL SHOWS THAN AN OVERLOAD OCCURRENCE HAD TAKEN PLACE PRIOR TO OR A TIME OF FAILURE."

    Description of Event or Problem · 1

    THE 2.0 X 28 MM PILOT DRILL BROKE IN THE PATIENT'S JAW (EMBEDDED) FOLLOWING THE INITIAL OSTEOTOMY WHILE USING THE SURGICAL GUIDE. DR STATED "DRILL DID NOT SEEM TO CUT". PATIENT WAS REFERRED IMMEDIATELY TO ORAL SURGEON TO REMOVE THE EMBEDDED DRILL AND TO COMPLETE THE IMPLANT PLACEMENT CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOHORIZON DENTAL IMPLANT DRILL DENTAL IMPLANT DRILL DZE BIOHORIZONS 122-028 102065

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention