BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKYLOS C/X IMPLANT B9.5 Ø 4.5/L9.5

    MDR report key: 5205269 · Received November 5, 2015

    Report

    Report Number
    9681851-2015-00020
    Event Type
    Injury
    Date Received
    November 5, 2015
    Date of Event
    February 5, 2015
    Report Date
    October 8, 2015
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    PMA / PMN Number
    K140347
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS 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. THIS REPORT IS FOR THE SEVENTH DEVICE. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE IMPLANT'S SURFACE PROPERTIES DID NOT SHOW ANY DEVIATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO WAS IMPLANTED WITH SEVEN ANKYLOS C/X IMPLANTS, HAD TO HAVE ALL OF THE IMPLANTS REMOVED DUE TO MOBILITY, PERIIMPLANTITIS AND "EXTRUSION FROM BONE". THE CLINICIAN EXPRESSED THE SUSPICION THAT THERE MAY BE AN ALLERGY TO TITANIUM. ACCORDING TO THE AVAILABLE INFORMATION THREE ANKYLOS C/X IMPLANTS WERE INSERTED IN THE MAXILLA OF A (B)(6) PATIENT. SIMULTANEOUS AUGMENTATION WITH "ALLOGRAFT PARTICULATE" AND "DBM PUTTY" WAS DONE. THE IMPLANTS WERE REMOVED FIVE MONTHS LATER. THE SAME PATIENT ALSO HAD FOUR IMPLANTS THAT WERE INSERTED IN THE MANDIBLE AND WERE REMOVED FOUR MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736628 ANKYLOS C/X IMPLANT B9.5 Ø 4.5/L9.5 IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH B120009678

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention