BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK® LAB DESIGNED ZIRCONIA ABUTMENT

    MDR report key: 3870551 · Received June 12, 2014

    Report

    Report Number
    0001038806-2014-00050
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    May 20, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR (VERIFICATION REPORT) AND DESIGN REVIEW SHOWS THE DEVICE TO BE WITHIN SPECIFICATION. BASED ON THE INVESTIGATION RESULTS AND THE INFORMATION PROVIDED BY THE CUSTOMER, NO SPECIFIC ROOT CAUSE CAN BE DETERMINED.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED BUT EVALUATION IS NOT YET COMPLETE. THIS EVENT IS BEING REPORTED DUE TO A PRECEDING MEDICAL DEVICE REPORT WHERE SURGICAL INTERVENTION DID NOT OCCUR. THIS EVENT IS A SUBSEQUENT MALFUNCTION. THE RISK TO THE PATIENT IS REMOTE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED TO HIS DENTIST THAT HIS ZIRCONIA ABUTMENT THAT HAD BEEN RESTORED FOR A YEAR HAD FRACTURED. THE DENTIST REPORTED THAT THERE WAS NO SERIOUS PATIENT INJURY, NO DETERIORATION IN PATIENT¿S HEALTH AND NO CONTRIBUTING CONDITIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348406 BELLATEK® LAB DESIGNED ZIRCONIA ABUTMENT BELLATEK® LAB DESIGNED ZIRCONIA ABUTMENT NHA BIOMET 3I N/A 1139464

    Patients

    Seq Age Sex Outcome Treatment
    1