BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMA ESTH CON ZI ABUT RD 5.0X1.5

    MDR report key: 2002389 · Received January 28, 2011

    Report

    Report Number
    3005990499-2011-00002
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    November 5, 2010
    Report Date
    January 6, 2011
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NHA
    PMA / PMN Number
    K072572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE TOP PORTION OF THE ABUTMENT, WITH THE CROWN ATTACHED WAS RETURNED FOR EVALUATION. THE TOP PORTION OF THE ABUTMENT WAS COMPLETELY ENCASED IN THE CROWN. THE DETACHED BOTTOM PORTION OF THE ABUTMENT, WHICH CONTAINS THE INTERNAL LOBES, WAS NOT RETURNED. THE AREA OF BREAKAGE WAS FOUND TO BE RAGGED AND UNEVEN. THE ABUTMENT FRACTURED APPROXIMATELY .87MM FROM THE CROWN. EVENTS OF THIS NATURE ARE USUALLY CAUSED BY THE PREPPING OF THE ABUTMENT PRIOR TO ATTACHING IT TO THE IMPLANT. MODIFICATION CAN LEAD TO ABUTMENT FRACTURE. DUE TO THE INHERENT NATURE OF MATERIALS USED FOR CERAMIC ABUTMENTS, FAILURE OF THIS NATURE ARE NOT UNEXPECTED. THE ROOT CAUSE OF THIS EVENT IS LIKELY ATTRIBUTED TO USER TECHNIQUE AND/OR OPERATIONAL CONTEXT. THIS PRODUCT IS SUPPLIED BY KEYSTONE DENTAL AS A NON-STERILE DEVICE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP MEDWATCH FORM WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A PATIENT HAD AN IMPLANT AND ABUTMENT PLACED ON (B)(6) 2009 (FDI DENTAL SITE UNKNOWN). THE PATIENT HAD INFORMED THE CLINICIAN THAT THE IMPLANT FELT LOOSE JUST PRIOR TO THE ABUTMENT, FRACTURING ON (B)(6) 2010. THE COMPLAINANT REPORTED THAT THE IMPLANT REMAINED VIABLE, AND THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ABUTMENT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMA ESTH CON ZI ABUT RD 5.0X1.5 NHA KEYSTONE DENTAL 45083K MM00293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK