BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYBRONPRO TL

    MDR report key: 1982646 · Received February 9, 2011

    Report

    Report Number
    2016150-2011-00031
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    November 15, 2010
    Report Date
    January 14, 2011
    Manufacturer
    EBI INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, 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 FIVE (5) MONTHS AFTER PLACEMENT DUE TO BRUXISM. THIS MDR IS THE FIRST OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBRONPRO TL IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 071115

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R