BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1675074 · Received May 5, 2010

    Report

    Report Number
    9611820-2010-00007
    Event Type
    Injury
    Date Received
    May 5, 2010
    Date of Event
    March 23, 2010
    Report Date
    April 6, 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

    ON APRIL 1, 2010, THE DOCTOR REPORTED THAT AN ABUTMENT FRACTURED. AN EVALUATION OF THE RETURNED PRODUCT INDICATED THAT THE ABUTMENT HAD BEEN CUSTOMIZED FOR THE PATIENT BY REDUCING ITS SIZE, MAKING IT UNABLE TO SUPPORT THE SUPERSTRUCTURE. AS A RESULT, THE SUPERSTRUCTURE BECAME LOOSE AND APPLIED ADDITIONAL STRESS ON THE ABUTMENT, CAUSING IT TO FRACTURE. THIS IS NOT A PRODUCT FAILURE.

    Description of Event or Problem · 1

    ON APRIL 6, 2010 A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS (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 844201

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R