BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® ZIREAL® POST 4.1(D) X 6(P) X 4(H) W/ZIREAL® HEXED SCREWS

    MDR report key: 3953720 · Received July 23, 2014

    Report

    Report Number
    0001038806-2014-00089
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    December 6, 2013
    Report Date
    December 7, 2013
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PD051973
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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, IT WAS FOUND THAT THE ZI-REAL ABUTMENT FRACTURED AND THE CORRECT SCREW WAS USED. THE CAUSE OF THE FRACTURE IS UNKNOWN. ALL (B)(4) ABUTMENTS FROM THIS LOT HAVE BEEN SHIPPED. TO DATE, THIS REPORT IS THE FIRST ASSOCIATED WITH THIS LOT AND IS CONSIDERED AN ISOLATED INCIDENT. THE REVIEW OF THE DHR RECORDS DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING DEVIATION THAT WOULD CAUSE THIS CONDITION.

    Description of Event or Problem · 1

    ICAP464

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432206 CERTAIN® ZIREAL® POST 4.1(D) X 6(P) X 4(H) W/ZIREAL® HEXED SCREWS CERTAIN® ZIREAL® POST 4.1(D) X 6(P) X 4(H) W/ZIREAL® HEXED SCREWS NHA BIOMET 3I N/A 1125364

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR