BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKYLOS C/X IMPLANT

    MDR report key: 2032264 · Received March 23, 2011

    Report

    Report Number
    9681851-2011-00006
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    DZE
    PMA / PMN Number
    K083805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS NO INDICATION THAT THE IMPLANT INVOLVED MALFUNCTIONED, DUE TO THE FACT THAT MEDICAL INTERVENTION WAS REQUIRED, AND THE POSSIBILITY THAT PERMANENT IMPAIRMENT MAY RESULT, THIS EVENT MEETS CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A PATIENT EXPERIENCED PARESTHESIA AFTER PLACEMENT OF AN ANKYLOS C/X IMPLANT. THE IMPLANT WAS REMOVED APPROXIMATELY TWO WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANKYLOS C/X IMPLANT DZE DENTSPLY TULSA DENTAL SPECIALTIES 0020039194

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention