BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1286843 · Received January 14, 2009

    Report

    Report Number
    9611820-2009-00001
    Event Type
    Injury
    Date Received
    January 14, 2009
    Report Date
    December 19, 2008
    Manufacturer
    SYBRON IMPLANT SOLUTIONS GMBH
    Product Code
    NHA
    PMA / PMN Number
    K053242
    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. THE DOCTOR WILL REPLACE THE BROKEN ABUTMENT WITH A NEW ABUTMENT. THE PRODUCT WAS RETURNED TO FACILITY, FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT INDICATED THAT THERE WERE DIRT PARTICLES (CERAMIC MATERIAL) IN BETWEEN THE THREADS OF THE CENTRAL SCREW. THEREFORE, THE ABUTMENT COULD NOT BE FIXED CORRECTLY. THE CAUSE OF THE ABUTMENT FRACTURE WAS MOBILITY OF THE ABUTMENT BECAUSE IT COULD NOT BE FIXED CORRECTLY. PLEASE SEE THE ATTACHED EVALUATION REPORT. THIS IS THE FINAL REPORT. - ATTACHMENT: [PITTEASY ABUTMENT 9611820-2009-00001 - EVALUATION.PDF]

    Description of Event or Problem · 1

    IN 2008, A DOCTOR REPORTED TO FACILITY, THAT A PITT EASY IMPLANT STANDARD ABUTMENT FRACTURED AT THE POST HEX.

    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 28 YR Other| R