BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1624361 · Received March 9, 2010

    Report

    Report Number
    9611820-2010-00003
    Event Type
    Injury
    Date Received
    March 9, 2010
    Report Date
    February 5, 2010
    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

    IT WAS REPORTED THAT A PATIENT HAD A FRACTURED ABUTMENT SCREW. THE PRODUCT WAS RETURNED TO SYBRON IMPLANT SOLUTIONS (B) (4) FOR EVALUATION. THE EVALUATION INDICATED THAT THE ABUTMENT SCREW MEETS PRODUCT SPECIFICATIONS AND THAT THE FRACTURE WAS CAUSED BY LOOSENING DUE TO OVERLOADING. THIS IS NOT A PRODUCT FAILURE.

    Description of Event or Problem · 1

    ON FEBRUARY 5, 2010, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS (B) (4) THAT A PATIENT HAD A PITT EASY ABUTMENT SCREW FRACTURE. THIS IS THE SECOND OF TWO INCIDENTS.

    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| R