BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYBRONPRO TL

    MDR report key: 1694323 · Received May 19, 2010

    Report

    Report Number
    2016150-2010-00077
    Event Type
    Injury
    Date Received
    May 19, 2010
    Date of Event
    April 12, 2010
    Report Date
    April 20, 2010
    Manufacturer
    EBI INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON APRIL 20, 2010, A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO TL IMPLANT DUE TO OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBRONPRO TL IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R