BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK® ZIRCONIA ABUTMENT

    MDR report key: 3835757 · Received May 28, 2014

    Report

    Report Number
    0001038806-2014-00041
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    September 23, 2011
    Report Date
    April 29, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PK052648
    Removal / Correction Number
    Z-1215-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE DHR (VERIFICATION REPORT) AND 3SHAPE REVIEW SHOWS THE DESIGN IS TO BE WITHIN SPECIFICATION. BASED ON THE INVESTIGATION RESULTS AND THE INFORMATION PROVIDED BY THE CUSTOMER, NO SPECIFIC ROOT CAUSE CAN BE DETERMINED. WHEN A FRACTURE OF AN ENCODE ZIRCONIA ABUTMENT IS OBSERVED ABOVE THE SEATING SURFACE OF THE ABUTMENT, THE ROOT CAUSE OF THE FRACTURE MAY BE RELATED TO THE TO THE DESIGN OF THE SCREW ACCESS HOLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED DUE TO A SINGLE PRECEDING MEDICAL DEVICE REPORT WHERE SURGICAL INTERVENTION DID OCCUR. THIS EVENT IS A SUBSEQUENT MALFUNCTION. THE RISK TO THE PATIENT IS REMOTE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED TO THE DENTIST THAT THE ZIRCONIA ABUTMENT RESTORED IN TOOTH SITE # 10 FRACTURED WHILE EATING. THE DENTIST FOUND THAT THE ABUTMENT HAD FRACTURED ABOVE THE HEX. THE DENTIST REPORTED THAT THERE WAS NO SERIOUS PATIENT INJURY, NO DETERIORATION IN PATIENT¿S HEALTH, NO UNANTICIPATED DELAYS IN PROCEDURES, NO SURGICAL COMPLICATIONS, NO VARIANCE IN SURGICAL TECHNIQUES, AND NO FOREIGN BODY RETAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314481 BELLATEK® ZIRCONIA ABUTMENT BELLATEK® ZIRCONIA ABUTMENT NHA BIOMET 3I N/A 1051664

    Patients

    Seq Age Sex Outcome Treatment
    1