BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1326451 · Received February 26, 2009

    Report

    Report Number
    9611820-2009-00003
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Report Date
    February 2, 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

    THE DOCTOR REPORTED THAT THE PATIENT IS DOING FINE. THE PATIENT'S ABUTMENT HAS NOT YET BEEN REPLACED SINCE THE PATIENT AND DOCTOR ARE DECIDING HOW TO PROCEED WITH THE PATIENT'S TREATMENT. THE PRODUCT WAS RETURNED TO SYBRON IMPLANT SOLUTIONS GMBH FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT INDICATED THAT THE FRACTURED SURFACE OF THE SCREW WAS VERY DENSE INDICATING THAT IT HAD FRACTURED SOME TIME AGO. THE ABUTMENT WAS USED IN A BRIDGE CONSTRUCTION WITH INSUFFICIENT PROSTHETICS. THE DEPOSITS AT THE CONNECTION LEVEL OF THE SCREW INDICATE THAT THE ABUTMENT WAS NOT CORRECTLY FIXED WITH THE IMPLANT WHICH LEAD TO LOOSENING AND THEN THE FRACTURE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IN 2009, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS GMBH THAT A PITT EASY IMPLANT STANDARD ABUTMENT FRACTURED AT THE SCREW.

    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 68 YR Other| R