BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1354905 · Received April 3, 2009

    Report

    Report Number
    9611820-2009-00007
    Event Type
    Malfunction
    Date Received
    April 3, 2009
    Report Date
    March 5, 2009
    Manufacturer
    SYBRON IMPLANT SOLUTIONS GMBH
    Product Code
    NHA
    PMA / PMN Number
    K053242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER INFORMATION WAS PROVIDED BY THE DOCTOR.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PITT EASY ABUTMENT ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA SYBRON IMPLANT SOLUTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other