BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKYLOS C/X IMPLANT

    MDR report key: 2031013 · Received March 16, 2011

    Report

    Report Number
    9681851-2011-00004
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    December 20, 2010
    Report Date
    February 14, 2011
    Manufacturer
    FRIADENT GMBH
    Product Code
    DZE
    PMA / PMN Number
    K083805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK IF THE ANKYLOS C/X IMPLANT USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS, IT IS POSSIBLE AN ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. EVAL OF THE IMPLANT'S SURFACE PROPERTIES DID NOT SHOW ANY DEVIATIONS.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT APPROX ONE WEEK AFTER PLACEMENT OF AN ANKYLOS C/X IMPLANT, A PT EXPERIENCED SEVERE PAIN. AS A RESULT, THE DEVICE WAS EXPLANTED APPROX TWO MONTHS LATER. THEREFORE, THIS EVENT WAS DETERMINED REPORTABLE VIA ASR. HOWEVER, ON (B)(6) 2011, FURTHER INFO WAS RECEIVED INDICATING THAT THE PT MAY HAVE EXPERIENCED AN ALLERGIC REACTION. IN ADDITION TO THE SYMPTOM INITIALLY REPORTED, THE PT, WHO HAS KNOWN ALLERGIES TO SEVERAL MEDICATIONS, ALSO EXPERIENCED SWELLING AND A BURNING SENSATION AND WAS ADMINISTERED A SAID AND NSAID AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANKYLOS C/X IMPLANT DZE FRIADENT GMBH 0020044308

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention