BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT-EASY ABUTMENT

    MDR report key: 1483759 · Received September 25, 2009

    Report

    Report Number
    9611820-2009-00017
    Event Type
    Injury
    Date Received
    September 25, 2009
    Report Date
    August 17, 2009
    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

    AN EVALUATION OF THE FRACTURED ABUTMENT REVEALED THAT A CERAMIC PARTICLE WAS LODGED BETWEEN THE THREADS, PREVENTING THE SCREW FROM BEING PROPERLY SEATED AND SUBSEQUENTLY RESULTING IN THE HEX FRACTURE. THIS IS NOT A PRODUCT FAILURE.

    Description of Event or Problem · 1

    ON AUGUST 17, 2009, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS GMBH THAT A PITT EASY IMPLANT ABUTMENT HEX HAD 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 37549

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R