BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1671233 · Received April 30, 2010

    Report

    Report Number
    9611820-2010-00006
    Event Type
    Injury
    Date Received
    April 30, 2010
    Report Date
    April 1, 2010
    Manufacturer
    SYBRON IMPLANT SOLUTIONS GMBH
    Product Code
    NHA
    PMA / PMN Number
    K053242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON APRIL 1, 2010, THE DOCTOR REPORTED THAT AN ABUTMENT FRACTURED. THE PRODUCT HAS NOT YET BEEN RETURNED TO SYBRON IMPLANT SOLUTIONS (B) (4) FOR EVALUATION. WHEN THE PRODUCT HAS BEEN RECEIVED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON APRIL 1, 2010, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS (B) (4) THAT A PITT EASY IMPLANT 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 Other| R