BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK® LAB DESIGNED ZIRCONIA ABUTMENT

    MDR report key: 6016644 · Received October 11, 2016

    Report

    Report Number
    0001038806-2016-00254
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    August 16, 2016
    Report Date
    September 15, 2016
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON VISUAL INSPECTION IT WAS DETERMINED THAT THE RETURNED COMPONENT IS A ZIRCONIA ABUTMENT AND NOT A ZIRCONIA COPING AS INITIALLY REPORTED. A PORTION OF THE ABUTMENT WAS RETURNED WITH A SCREW AND THE REPORTED FRACTURE WAS CONFIRMED. 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. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT RETURNED TO MANUFACTURER.PRODUCT CODE ELZ

    Description of Event or Problem · 1

    THE DENTIST REPORTED THAT THE ZIRCONIA ABUTMENT FRACTURED AT THE CONNECTION.

    Description of Event or Problem · 1

    THE DENTIST REPORTED THAT ZIRCONIA COPING FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669117 BELLATEK® LAB DESIGNED ZIRCONIA ABUTMENT ZIRCONIA ABUTMENT NHA BIOMET 3I 1090399

    Patients

    Seq Age Sex Outcome Treatment
    1