BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® ZIREAL® POST 4.1(D) X 5(P) X 4(H) W/ZIREAL® HEXED SCREWS

    MDR report key: 4113565 · Received September 24, 2014

    Report

    Report Number
    0001038806-2014-00116
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PK991947
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: PRODUCT HAS NOT BEEN RETURNED AT THIS TIME; (B)(6) 2014 THEREFORE COMPLAINT CANNOT BE VERIFIED. NO CONCLUSION CAN BE DRAWN. THE LOT NUMBER PROVIDED ON THE COMPLAINT REPORT WAS NOT VALID.

    Description of Event or Problem · 1

    THE DOCTOR INDICATED THAT THE ZIRCONIA ABUTMENT FRACTURED AFTER BEING IN PATIENTS MOUTH FOR 3 MONTHS. IT WAS ALSO REPORTED THAT THE PATIENT DID NOT SUFFER A SERIOUS INJURY OR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596041 CERTAIN® ZIREAL® POST 4.1(D) X 5(P) X 4(H) W/ZIREAL® HEXED SCREWS ZIRCONIA ABUTMENT NHA BIOMET 3I N/A 57495365

    Patients

    Seq Age Sex Outcome Treatment
    1