BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYBRONPRO TL

    MDR report key: 2011069 · Received March 8, 2011

    Report

    Report Number
    2016150-2011-00047
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 11, 2011
    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 (B)(6), 2011 A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO TL IMPLANT APPROXIMATELY ELEVEN (11) MONTHS AFTER PLACEMENT DUE TO TRAUMA CAUSED BY THE OCCLUSION OF THE PATIENT'S DENTURES. THIS MDR IS THE FIRST OF THREE REPORTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R