BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLUS IMPLANT

    MDR report key: 2003335 · Received March 1, 2011

    Report

    Report Number
    3001617766-2011-00001
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 31, 2011
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING
    Product Code
    DZE
    PMA / PMN Number
    K061319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT A PATIENT LOST AN IMPLANT DUE TO AN INFECTION THAT OCCURRED IMMEDIATELY AFTER PLACEMENT. THE IMPLANT WAS REMOVED AND THE BONE WAS GRAFTED. THE PATIENT IS DOING FINE. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS IS CURRENTLY IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A DOCTOR REPORTED TO IMPLANT DIRECT SYBRON MANUFACTURING THAT A PATIENT LOST AN IMPLANT IMMEDIATELY AFTER PLACEMENT DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLUS IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE IMPLANT DIRECT SYBRON MANUFACTURING 24449

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R