BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK® ZIRCONIA ABUTMENT

    MDR report key: 4152697 · Received October 8, 2014

    Report

    Report Number
    0001038806-2014-00129
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 9, 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
    KS, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR AND 3SHAPE REVIEW SHOWS THAT THE DESIGN WAS WITHIN SPECIFICATION. BASED ON THE INVESTIGATION, VISUAL ANALYSIS, AND THE INFORMATION PROVIDED BY THE CUSTOMER, NO SPECIFIC ROOT CAUSE COULD BE DETERMINED. WHEN THE FRACTURE OF A ZIRCONIA ABUTMENT IS OBSERVED ABOVE THE SEATING SURFACE OF THE ABUTMENT, THE ROOT CAUSE OF THE FRACTURE MAY BE RELATED TO THE DESIGN OF THE SCREW ACCESS HOLE, WHICH ALSO RESULTED IN THE RECALL.

    Description of Event or Problem · 1

    ZIRCONIA ABUTMENT FRACTURED ABOVE COLLAR. THERE WAS NO REPORTED INJURY AS A RESULT OF THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630387 BELLATEK® ZIRCONIA ABUTMENT ZIRCONIA ABUTMENT NHA BIOMET 3I N/A 1153834

    Patients

    Seq Age Sex Outcome Treatment
    1