BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKYLOS C/X IMPLANT

    MDR report key: 2232489 · Received August 25, 2011

    Report

    Report Number
    9681851-2011-00019
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 11, 2011
    Manufacturer
    FRIADENT GMBH
    Product Code
    DZE
    PMA / PMN Number
    K083805
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFORMATION BY THE DENTIST, HE WAS AWARE OF THE FACT - DUE TO THE RADIOGRAPHIC ASSESSMENT - THAT THE LENGTH OF 11MM WAS RISKY TO PLACE, BUT HE WANTED TO MAXIMALLY UTILIZE THE AVAILABLE VERTICAL HEIGHT. HE STATED THAT HE PROBABLY TOUCHED THE BONY WALL ABOVE THE NERVE DURING IMPLANT PLACEMENT, WHICH SEEMS TO HAVE CAUSED THE PERSISTENT PARAESTHESIA. HOWEVER, HE IS CONVINCED THAT THE NUMBNESS IN THE PT'S LIP WILL DISAPPEAR COMPLETELY AS IT IS CURRENTLY DECREASING, BUT IT IS STILL DETECTABLE. SINCE THERE IS A FAST IMPROVEMENT OF THE SYMPTOMS IT CAN BE ASSUMED THAT THE PT WILL FULLY RECOVER. GENERALLY, SUCH CASES ARE NOT UNK IN IMPLANTOLOGY AND ARE USUALLY CAUSED BY AN INSUFFICIENT PLANNING OF THE IMPLANTATION. THE IMPLANT WAS RETURNED ADN EVALUATED AND FOUND TO BE WITHIN SPECIFICATION. WHILE THE DEVICE DID NOT MALFUNCTIONED, DUE TO THE FACT THAT MEDICAL INTERVENTION WAS REQUIRED THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE IMPLANT WAS EVALUATED FOR DIAMETER AND LENGTH MEASUREMENTS AND FOUND TO BE IN SPECIFICATION.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT AFTER PLACEMENT, AND ANKYLOS C/X IMPLANT SEEMS TO HAVE AFFECTED THE ID NERVE, RESULTING IN PARAESTHESIA. AS A RESULT, THE IMPLANT WAS REMOVED EIGHT WEEKS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention