BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED ABUTMENT

    MDR report key: 1221743 · Received November 7, 2008

    Report

    Report Number
    9681239-2008-00001
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Report Date
    September 8, 2008
    Manufacturer
    SYBRON IMPLANT SOLUTIONS CORP.
    Product Code
    NHA
    PMA / PMN Number
    K952434
    Product Problem
    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.

    Description of Event or Problem · 1

    IN 2008, 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 ANGLED ABUTMENT ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA SYBRON IMPLANT SOLUTIONS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other