BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1695289 · Received May 20, 2010

    Report

    Report Number
    9611820-2010-00008
    Event Type
    Injury
    Date Received
    May 20, 2010
    Report Date
    April 22, 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 (B) (4), 2010, THE DOCTOR REPORTED THAT AN ABUTMENT HEX SCREW FRACTURED. THE EVALUATION OF THE RETURNED PRODUCT INDICATED THAT THE HEX SCREW FRACTURED AS A RESULT OF OVERLOADING. THE ABUTMENT WAS USED AS A POST FOR A SINGLE TOOTH RESTORATION IN THE REGION OF THE FIRST MOLAR, WHICH RESULTED IN OVERSTRESSING THE HEX SCREW AND THE SUBSEQUENT FRACTURE. THE PRODUCT MET SPECIFICATIONS. THIS IS NOT A PRODUCT FAILURE.

    Description of Event or Problem · 1

    ON (B) (6), 2010 A DOCTOR REPORTED TO (B) (4) THAT A PITT EASY ABUTMENT HEX 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 823506

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R