BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYBRONPRO TL

    MDR report key: 1951267 · Received January 6, 2011

    Report

    Report Number
    2016150-2011-00004
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    October 6, 2010
    Report Date
    December 17, 2010
    Manufacturer
    EBI INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2010 A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO TL IMPLANT APPROXIMATELY ELEVEN (11) MONTHS AFTER PLACEMENT DUE TO BIOMECHANICAL OVERLOAD. IN ADDITION, THE DOCTOR STATED THAT THE IMPLANT WAS PLACED IN GRAFTED BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBRONPRO TL IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 081150

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R