BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1342837 · Received March 13, 2009

    Report

    Report Number
    9611820-2009-00006
    Event Type
    Injury
    Date Received
    March 13, 2009
    Report Date
    February 13, 2009
    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 DID NOT SPECIFY THE CAUSE OF THE IMPLANT LOSS BUT REPORTED THAT THE PATIENT IS DOING FINE. THE DOCTOR WILL REPLACE THE BROKEN ABUTMENT WITH A NEW ABUTMENT. THE PRODUCT WAS NOT RETURNED TO FACILITY FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2009, A DOCTOR REPORTED TO FACILITY THAT A PITT EASY IMPLANT ABUTMENT FRACTURED AFTER OVER TEN YEARS OF USE.

    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 62 YR Other| R