BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAGLAZE PORCELAIN POLISHER (PRE-POLISH)

    MDR report key: 1198460 · Received October 15, 2008

    Report

    Report Number
    1645240-2008-11002
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    April 24, 2006
    Report Date
    December 27, 2006
    Manufacturer
    AXIS DENTAL CORP.
    Product Code
    EHJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE ADVERSE EVENT WAS REPORTED TO THE MFR THROUGH AN ATTORNEY OF THE PATIENT. NOTIFICATION ALLEGES THAT THE P353-3 POLISHER (PURCHASED IN OUR LS-514 LOGIC SET) SHATTERED WHILE ADJUSTING A PRE-FORMED CERAMIC CROWN. THE SPECIFIC LOT NUMBER IS NOT AVAILABLE AS THE INSTRUMENT WAS DISPOSED OF BY THE DOCTOR ON THE DAY OF THE INCIDENT. NEITHER THE DEALER COMPANY NOR DATE OF PURCHASE IS KNOWN. SINCE NEITHER THE LOT NUMBER NOR DATE OF PURCHASE CAN BE DETERMINED, WE TESTED POLISHERS TAKEN FROM CURRENT STOCK. WE POLISHED A CERAMIC CROWN WITH THREE P353-3 POLISHERS, LOT NUMBER S12.003, AT A SPEED OF LESS THAN 5000 RPM. POLISHERS PERFORMED ACCORDING TO EXPECTATIONS. NO BREAKAGE OR FRAGMENTING WAS OBSERVED. WE HAVE RECEIVED NO OTHER COMPLAINTS OF THIS NATURE INVOLVING THIS ITEM.

    Description of Event or Problem · 1

    A PATIENT ALLEGES THE DENTIST HAD PERFORMED A ROOT CANAL ON TOOTH NO. 29 AND HAD PLACED A PRE-FORMED POST AND CROWN. DURING THE TREATMENT THE POLISHING BUR SHATTERED AND FRACTURED THE TOOTH. SOME OF THE PIECES OF THE POLISHING BUR WERE INGESTED BY THE PATIENT, AND THE PATIENT HAD TO SEEK MEDICAL ATTENTION. NO REPORT FROM THE DENTIST WAS RECEIVED REGARDING THE ALLEGED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERAGLAZE PORCELAIN POLISHER (PRE-POLISH) SMALL CONE SHAPED POLISHING POINT (EHL) EHJ AXIS DENTAL CORP. P353-3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization