BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1278583 · Received January 6, 2009

    Report

    Report Number
    9611820-2008-00002
    Event Type
    Injury
    Date Received
    January 6, 2009
    Report Date
    December 10, 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 REPLACED THE BROKEN ABUTMENT WITH A NEW BALL-HEAD POST WITHOUT ANY INCIDENT. THE PRODUCT WAS RETURNED TO SYBRON IMPLANT SOLUTIONS GMBH FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT INDICATED THAT THE CAUSE OF THE ABUTMENT FRACTURE WAS STRAIN THROUGH PROSTHESIS, AFTER ABUTMENT LOOSENING INTO IMPLANT-THREAD. PLEASE SEE THE ATTACHED EVALUATION REPORT. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IN 2008, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS GMBH THAT A PITT EASY IMPLANT BALL-HEAD POST SCREW ABUTMENT FRACTURED, DUE TO LOOSENING INTO THE THREAD.

    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 80 YR Other| R