BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1972098 · Received January 27, 2011

    Report

    Report Number
    9611820-2011-00003
    Event Type
    Injury
    Date Received
    January 27, 2011
    Report Date
    December 29, 2010
    Manufacturer
    SYBRON IMPLANT SOLUTIONS GMBH
    Product Code
    NHA
    PMA / PMN Number
    K053242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE RETURNED SCREW INDICATED THAT THERE WAS NO DEFECTIVE MATERIAL. A VISUAL INSPECTION INDICATED THAT THE SCREW FRACTURED AT THE SCREW HEAD. THIS TYPE OF FRACTURE IS POSSIBLY DUE TO THE SUPERSTRUCTURE BEING UNDER CONSTANT TENSION OR THE SCREW BEING TIGHTENED WITH UNCONTROLLED TORQUE. THIS IS NOT A PRODUCT FAILURE. PLEASE NOTE THAT THIS REPORT IS BEING SUBMITTED BY SYBRON IMPLANT SOLUTIONS (B)(4) (THE MANUFACTURER) ON BEHALF OF SYBRON IMPLANT SOLUTIONS (THE IMPORTER) PER REPORTING EXEMPTION (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2010 A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS (B)(4) THAT FIVE (5) PITT EASY ABUTMENT SCREWS FRACTURED. THIS MDR IS THE SECOND OF FIVE REPORTS.

    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