BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKYLOS UNKNOWN

    MDR report key: 2860434 · Received November 5, 2012

    Report

    Report Number
    9681851-2012-00010
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    FRIADENT GMBH
    Product Code
    DZE
    PMA / PMN Number
    K040170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTIST'S EXPLANATION FOR THE OCCURRENCE OF THE NUMBNESS SEEMS TO BE VERY UNLIKELY. THE AETIOLOGY OF A BONE MARROW OEDEMA IS USUALLY RELATED TO A SEVERE INFLAMMATION PROCESS; IN CONTRAST, OVERHEATING OF THE BONE TYPICALLY LEADS TO A NECROSIS. HOWEVER THIS IS DEVELOPING OVER WEEKS RATHER THAN HOURS. FROM THE AVAILABLE INFORMATION IT SEEMS TO BE MORE LIKELY THAT THE NERVE TRAUMA WAS CAUSED BY THE ANAESTHESIA. THIS IS IN ACCORDANCE WITH THE LATEST INFORMATION THAT THE NUMBNESS IS DECREASING AND THE PATIENT IS RECOVERING. HOWEVER, BECAUSE THERE WAS MEDICAL INTERVENTION IN THIS EVENT, IT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT, AN ANKYLOS ABUTMENT FRACTURE OCCURRED. THE DENTIST ATTEMPTED TO REMOVE THE RESIDUAL FRAGMENTS OF THE ABUTMENT, BUT THIS ATTEMPT FAILED. THE DENTIST DECIDED TO COVER THE IMPLANT TEMPORARILY AND SEND THE PATIENT AWAY. THE NEXT DAY, THE PATIENT RETURNED AND WAS COMPLAINING ABOUT NUMBNESS OF THE LOWER LIP. ACCORDING TO AVAILABLE INFORMATION, THE DENTIST ASSUMED THAT THE HEAT THAT WAS GENERATED DURING THE DRILLING PROCESS FOR HARVESTING THE FRAGMENTS OUT OF THE INTERNAL IMPLANT CONNECTION HAS CAUSED AN OEDEMA. THUS THE RELATED SWELLING PUT PRESSURE ON THE NERVE. IN CONSEQUENCE, THE NUMBNESS OCCURRED. THE AVAILABLE X-RAY REVEALED THAT THE IMPLANT IS PLACED IN AN ADEQUATE DISTANCE TO THE MANDIBULAR NERVE CANAL. THE DENTIST FORWARDED THE PATIENT TO A MAXILLOFACIAL SURGEON FOR FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANKYLOS UNKNOWN DZE FRIADENT GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention