BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1797593 · Received August 12, 2010

    Report

    Report Number
    9611820-2010-00012
    Event Type
    Injury
    Date Received
    August 12, 2010
    Report Date
    July 12, 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

    THE FRACTURED SCREW WAS NOT RETURNED TO SYBRON IMPLANT SOLUTIONS (B)(4) FOR EVALUATION. NO DETAILS WERE PROVIDED REGARDING THE PATIENT'S CONDITION OR THE CAUSE OF THE FRACTURE. BECAUSE THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, NEITHER AN EVALUATION OR A REVIEW OF THE MANUFACTURING RECORDS COULD BE CONDUCTED. THE CAUSE OF THE FRACTURE REMAINS INCONCLUSIVE, AS NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 1

    ON JULY 12, 2010, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS GMBH 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