BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK® ZIRCONIA ABUTMENT

    MDR report key: 4228315 · Received November 5, 2014

    Report

    Report Number
    0001038806-2014-00146
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Report Date
    October 1, 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
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. THIS EVENT IS BEING REPORTED DUE TO A SINGLE PROCEEDING MEDICAL DEVICE REPORT WHERE SURGICAL INTERVENTION OCCURRED. THIS EVENT IS A SUBSEQUENT MALFUNCTION. THE RISK TO PATIENT HEALTH IS REMOTE. INVESTIGATION OF OTHER COMPLAINTS WITH SIMILAR ABUTMENTS THAT WERE FRACTURED CONCLUDED THE FRACTURE WAS RELATED TO THE DESIGN OF THE HEX AND BOSS CONNECTION AND TO THE SCREW ACCESS HOLE WHICH LED TO THE RECALL.

    Description of Event or Problem · 1

    THE DENTIST REPORTED THE ZIRCONIA ABUTMENT IN TOOTH SITE #9 BROKE WHILE THE PATIENT WAS EATING PORRIDGE. THE ABUTMENT WENT UP IN THE SUCTION UNIT AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711306 BELLATEK® ZIRCONIA ABUTMENT ZIRCONIA ABUTMENT NHA BIOMET 3I N/A 1078345

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR