BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1742748 · Received June 30, 2010

    Report

    Report Number
    9611820-2010-00010
    Event Type
    Injury
    Date Received
    June 30, 2010
    Report Date
    June 4, 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

    AN EVALUATION COULD NOT BE CONDUCTED ON THE FRACTURED ABUTMENT SCREW, AS IT COULD NOT BE REMOVED FROM THE IMPLANT. THE CROWN, ABUTMENT, AND THE REMAINING PORTION OF THE SCREW WERE NOT RETURNED TO SYBRON IMPLANT SOLUTIONS (B)(4) FOR EVALUATION. NO X-RAYS WERE PROVIDED BY THE DOCTOR, NOR WERE ANY DETAILS REGARDING PATIENT OUTCOME. NO PART NUMBER OR LOT NUMBER WAS PROVIDED FOR THE ABUTMENT SCREW, THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. THE CAUSE OF THE FRACTURE REMAINS INCONCLUSIVE, AS NO FURTHER INVESTIGATION IS POSSIBLE.

    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 Other| R