BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITT EASY ABUTMENT

    MDR report key: 1238223 · Received November 21, 2008

    Report

    Report Number
    9611820-2008-00001
    Event Type
    Injury
    Date Received
    November 21, 2008
    Report Date
    October 29, 2008
    Manufacturer
    SYBRON IMPLANT SOLUTIONS GMBH
    Product Code
    NHA
    PMA / PMN Number
    K053242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT THE PATIENT IS DOING FINE. THE DOCTOR HAD THE PROSTHESIS PLACED IN 2007. IN 2008, THE PATIENT WENT BACK TO SEE THE DOCTOR BECAUSE OF THE FRACTURED ABUTMENT. DURING THIS 1 ½ YEAR TIME PERIOD, THE PATIENT HAD NEVER HAD FOLLOW-UP APPOINTMENTS WITH THE DOCTOR. THE DOCTOR EVALUATED THAT A REBASE OF THE PROSTHESES SHOULD HAVE TAKEN PLACE MUCH EARLIER BECAUSE HE NOTICED THAT THE ABUTMENT WAS OVERLOADED THE ENTIRE TIME. THE PRODUCT WAS RETURNED TO SYBRON IMPLANT SOLUTIONS GMBH FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT INDICATED THAT THERE WAS NO MATERIAL FAILURE; PLEASE SEE THE ATTACHED MICROSCOPIC PICTURES. THE CAUSE OF THE ABUTMENT FRACTURE WAS OVERLOADING. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IN 2008, A DOCTOR REPORTED TO COMPANY THAT A PITT EASY IMPLANT ABUTMENT HAD FRACTURED DURING USE IN A PATIENT'S MOUTH, BUT NOTHING WAS SWALLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PITT EASY ABUTMENT ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA SYBRON IMPLANT SOLUTIONS GMBH 40051 706118D1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other