BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYBRONPRO TL

    MDR report key: 1832855 · Received September 13, 2010

    Report

    Report Number
    2016150-2010-00149
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 13, 2010
    Manufacturer
    EBI INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON AUGUST 13, 2010, A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO TL IMPLANT THREE (3) MONTHS AFTER PLACEMENT DUE TO UNKNOWN CAUSES. THIS IS THE SECOND OF THREE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBRONPRO TL IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 081025

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R