BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYBRONPRO XRT

    MDR report key: 2160339 · Received July 13, 2011

    Report

    Report Number
    2016150-2011-00148
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    May 24, 2011
    Report Date
    July 5, 2011
    Manufacturer
    EBI INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011 A DOCTOR ALLEGED THAT A PATIENT LOST A SYBRONPRO XRT IMPLANT APPROXIMATELY SEVEN (7) MONTHS AFTER PLACEMENT DUE TO UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBRONPRO XRT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 081103

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R