BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYBRONPRO XRT

    MDR report key: 1972096 · Received January 27, 2011

    Report

    Report Number
    2016150-2011-00012
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    November 8, 2010
    Report Date
    December 30, 2010
    Manufacturer
    EBI INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010 A DOCTOR REPORTED THAT A PATIENT LOST TWO (2) SYBRONPRO XRT IMPLANTS APPROXIMATELY ONE MONTH AFTER PLACEMENT DUE TO UNKNOWN CAUSES. THIS MDR IS THE FIRST OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBRONPRO XRT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 091182

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R