BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 2003400 · Received March 1, 2011

    Report

    Report Number
    9611820-2011-00008
    Event Type
    Injury
    Date Received
    March 1, 2011
    Report Date
    January 31, 2011
    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 ABUTMENT HEX FRACTURE WAS LIKELY DUE TO BIOMECHANICAL OVERLOADING DURING THE FIVE YEARS IN WHICH THE ABUTMENT WAS USED AS A POST FOR A TELESCOPIC RESTORATION IN THE REGION OF THE CANINE TEETH. AN EVALUATION OF THE RETURNED ABUTMENT INDICATED THAT THE ABUTMENT MET PRODUCT SPECIFICATIONS. IT MAY THEREFORE BE CONCLUDED THAT THE FRACTURE WAS NOT DUE TO A PRODUCT FAILURE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2011 A DOCTOR REPORTED TO (B)(4) THAT A PITT EASY ABUTMENT 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 61 YR Other| R