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: 3953841 · Received July 23, 2014

    Report

    Report Number
    0001038806-2014-00077
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 17, 2012
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PD051973
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME BIOMET 3I BECAME AWARE OF THIS EVENT, IT WAS NOT CONSIDERED REPORTABLE. SUBSEQUENT REVIEW OF REPORTING POLICIES HAS DETERMINED ABUTMENT FRACTURES FOR THIS PRODUCT TYPE SHOULD BE REPORTED AS MALFUNCTIONS. THIS EVENT WAS IDENTIFIED AS ONE REQUIRING RETROSPECTIVE REPORTING BASED ON A RECENT AUDIT OF COMPLAINT DATA AND ENHANCEMENTS MADE TO REPORTING POLICIES APPLICABLE TO ABUTMENT FRACTURES. INVESTIGATION RESULTS: UPON VISUAL INSPECTION, FOUND THAT THE CERAMIC HAS BROKEN OFF, THEREFORE DOES NOT FUNCTION WITHIN REQUIRED MANUFACTURING SPECIFICATION. THIS WAS LIKELY CAUSED BY IMPROPERLY TORQUED COMPONENT OR PARAFUNCTIONAL HABITS OF THE PATIENT.

    Description of Event or Problem · 1

    THE DOCTOR INDICATED THAT THE PATIENT RETURNED TO THE DENTAL PRACTICE WITH A FRACTURED ZI-REAL ABUTMENT, PART OF ABUTMENT AND SCREW WAS REMOVED FROM THE IMPLANT AT THAT TIME. IT WAS ALSO REPORTED THAT THE PATIENT DID NOT SUFFER AN INJURY OR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431271 CERTAIN® ZIREAL® POST 4.1(D) X 5(P) X 4(H) W/ZIREAL® HEXED SCREWS CERTAIN® ZIREAL® POST 4.1(D) X 5(P) X 4(H) W/ZIREAL® HEXED SCREWS NHA BIOMET 3I N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1