BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMA ESTH CON ZI ABUT SD 4.0X2MM

    MDR report key: 2002385 · Received January 28, 2011

    Report

    Report Number
    3005990499-2011-00003
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    November 5, 2010
    Report Date
    January 5, 2011
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NHA
    PMA / PMN Number
    K072572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS CONFIRMED THE COMPLAINT CONDITION. THE ABUTMENT WAS OBSERVED TO BE FRACTURED INTO TWO PIECES. THE TOP PORTION OF THE ABUTMENT, WITH CROWN ATTACHED WAS RETURNED IN ONE PIECE. THE LOBE SECTION OF THE ABUTMENT WAS FOUND TO HAVE BECOME COMPLETELY SEPARATED FROM THE CUFF PORTION OF THE ABUTMENT. THE AREA OF BREAKAGE ON BOTH PIECES WAS FOUND TO BE RAGGED AND UNEVEN. FRACTURES OF THIS NATURE ARE USUALLY CAUSED BY EXCESSIVE TORQUE USED TO SECURE THE ABUTMENT SCREW. A TORQUE SETTING OVER THE RECOMMENDED 30NCM AND/OR MISALIGNMENT DURING PLACEMENT CAN RESULT IN FRACTURES TOWARD THE BASE OF THE ZIRCONIA ABUTMENT. 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), 2010 (FDI DENTAL SITE UNKNOWN). THE CLINICIAN REPORTED THAT THE ABUTMENT FRACTURED ON (B)(6), 2010. THERE WAS NO INDICATION FROM THE COMPLAINANT OF ANY ADVERSE EFFECT 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 SD 4.0X2MM NHA KEYSTONE DENTAL 45081K MM01142

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK