BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYBRONPRO XRT

    MDR report key: 1852586 · Received October 4, 2010

    Report

    Report Number
    2016150-2010-00160
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 13, 2010
    Manufacturer
    EBI INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 13, 2010, A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO XRT IMPLANT THREE (3) MONTHS AFTER PLACEMENT DUE TO NON-OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBRONPRO XRT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 081088

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R