BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYBRONPRO TL

    MDR report key: 1312663 · Received February 17, 2009

    Report

    Report Number
    2016150-2009-00007
    Event Type
    Injury
    Date Received
    February 17, 2009
    Date of Event
    December 11, 2008
    Report Date
    January 19, 2009
    Manufacturer
    EBI INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON JANUARY 19, 2009, A DOCTOR REPORTED THAT A PATIENT LOST A DENTAL IMPLANT ABOUT 9 WEEKS AFTER THE IMPLANT PLACEMENT, DUE TO POOR BONE QUALITY. THE DOCTOR ALSO INDICATED THAT BONE AUGMENTATION MATERIAL WAS USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBRONPRO TL IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 081011

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R