BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYBRONPRO TL

    MDR report key: 2110050 · Received June 1, 2011

    Report

    Report Number
    2016150-2011-00117
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 12, 2011
    Manufacturer
    EBI INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011 A DOCTOR ALLEGED THAT A PATIENT LOST A SYBRONPRO TL IMPLANT APPROXIMATELY FOUR (4) MONTHS AFTER PLACEMENT DUE TO NO OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBRONPRO TL IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 101096

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R