BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYBRONPRO TL

    MDR report key: 2110769 · Received June 1, 2011

    Report

    Report Number
    2016150-2011-00125
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 23, 2011
    Manufacturer
    EBI INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MT, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011 A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO TL IMPLANT NINE (9) MONTHS AFTER PLACEMENT DUE TO BIOMECHANICAL OVERLOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBRONPRO TL IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 071112

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R