BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1972077 · Received January 27, 2011

    Report

    Report Number
    9611820-2011-00001
    Event Type
    Injury
    Date Received
    January 27, 2011
    Report Date
    December 29, 2010
    Manufacturer
    SYBRON IMPLANT SOLUTIONS GMBH
    Product Code
    NHA
    PMA / PMN Number
    K053242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW HAD BEEN IN PLACE FOR TEN YEARS AND THE FRACTURE WAS LIKELY DUE TO FATIGUE AFTER CONSTANT TENSION. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER WAS PROVIDED; THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. PLEASE NOTE THAT THIS REPORT IS BEING SUBMITTED BY SYBRON IMPLANT SOLUTIONS (B)(4) (THE MANUFACTURER) ON BEHALF OF SYBRON IMPLANT SOLUTIONS (THE IMPORTER) PER REPORTING EXEMPTION (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2010, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS (B)(4) THAT A PITT EASY ABUTMENT SCREW 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 45 YR Other| R