BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK® LAB DESIGNED ZIRCONIA ABUTMENT

    MDR report key: 4131544 · Received October 1, 2014

    Report

    Report Number
    0001038806-2014-00119
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 3, 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
    MO, US
    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 PRECEDING 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 DOCTOR INDICATED THAT THE ZIRCONIA ABUTMENT FRACTURED. THERE WAS NO REPORTED SERIOUS INJURY OR INFECTION ASSOCIATED WITH THIS REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611437 BELLATEK® LAB DESIGNED ZIRCONIA ABUTMENT DENTAL IMPLANT ZIRCONIA ABUTMENT NHA BIOMET 3I N/A 1125359

    Patients

    Seq Age Sex Outcome Treatment
    1