BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 2003399 · Received March 1, 2011

    Report

    Report Number
    9611820-2011-00007
    Event Type
    Injury
    Date Received
    March 1, 2011
    Report Date
    January 31, 2011
    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 DOCTOR DID NOT PROVIDE A CAUSE FOR THE ABUTMENT FRACTURE; HOWEVER THE DOCTOR STATED THAT THE PATIENT IS DOING FINE AND RECEIVED A NEW BRIDGE. AN EVALUATION OF THE RETURNED ABUTMENT INDICATED THAT IT MET PRODUCT SPECIFICATIONS. THEREFORE IT MAY BE CONCLUDED THAT THE FRACTURE WAS NOT DUE TO A PRODUCT FAILURE. PLEASE NOTE THAT THIS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2011 A DOCTOR REPORTED TO (B)(4) THAT A PITT EASY ABUTMENT 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 45 YR Other| R