BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPORE ABUTMENT

    MDR report key: 1377326 · Received May 9, 2009

    Report

    Report Number
    9681239-2009-00004
    Event Type
    Malfunction
    Date Received
    May 9, 2009
    Date of Event
    March 31, 2009
    Report Date
    April 9, 2009
    Manufacturer
    SYBRON IMPLANT SOLUTIONS CORP.
    Product Code
    NHA
    PMA / PMN Number
    K952434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT THE PATIENT IS DOING FINE, AND THAT THE FRACTURED ABUTMENT WILL BE REPLACED.

    Description of Event or Problem · 1

    IN 2009, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS CORP. THAT AN ABUTMENT HAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPORE ABUTMENT ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA SYBRON IMPLANT SOLUTIONS CORP. 4391044

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other