BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKYLOS C/X IMPLANT

    MDR report key: 3092387 · Received April 30, 2013

    Report

    Report Number
    9681851-2013-00005
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 4, 2013
    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

    THE INVESTIGATION OF THE RECEIVED IMPLANT DID NOT SHOW ANY DEVIATION FROM THE SPECIFICATION, SO IT CAN BE CONCLUDED THAT THIS ISSUE WAS CAUSED BY A TREATMENT PLANNING FAILURE. IN THIS CASE, IMPLANT PLACEMENT IS CONTRAINDICATED DUE TO THE FRAGILE MANDIBLE. WHILE THE DEVICE INVOLVED DID NOT MALFUNCTION IN THIS EVENT. BECAUSE A SERIOUS INJURY OCCURRED, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT (B)(6) EDENTULOUS PT RECEIVED TWO IMPLANTS IN THE INTERFORAMINAL REGION OF THE MANDIBLE AND AFTER APPROX 6 WEEKS A FRACTURE OF THE MANDIBLE AROUND THE IMPLANT IN REGION 33 (#22) OCCURRED AND THE IMPLANT WAS DISLOCATED CAUDALLY. THE OPG AT HAND WAS TAKEN SUBSEQUENTLY AND IS DISPLAYING THE FRACTURE BUT AS WELL AN EXTREMELY ATROPHIED MANDIBULAR BONE. ALTHOUGH THE DENTIST SELECTED A VERY SHORT IMPLANT LENGTH, THE IMPLANTS WERE OBVIOUSLY NOT COVERED BY BONE COMPLETELY; MOREOVER, THE APICAL PART OF THE IMPLANT IN REGION 43 (#26) THAT IS STILL IN PLACE IS PROTRUDING THROUGH THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188756 ANKYLOS C/X IMPLANT DZE FRIADENT GMBH B120006274

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention