BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYBRONPRO TL

    MDR report key: 1718944 · Received June 11, 2010

    Report

    Report Number
    2016150-2010-00083
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    March 23, 2010
    Report Date
    May 12, 2010
    Manufacturer
    EBI INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON MAY 12, 2010, A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO TL IMPLANT SEVEN (7) MONTHS AFTER PLACEMENT DUE TO LACK OF INTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBRONPRO TL IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 061049

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R