BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3I INCISE ZR COPING SHADE 1

    MDR report key: 5375302 · Received January 18, 2016

    Report

    Report Number
    0001038806-2016-00009
    Event Type
    Malfunction
    Date Received
    January 18, 2016
    Report Date
    December 21, 2015
    Manufacturer
    BIOMET 3I
    Product Code
    NSP
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE ELZ.(B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT DID NOT RETURN FOR EVALUATION, THEREFORE THE COMPLAINT COULD NOT BE VERIFIED. THE DEVICE HISTORY RECORD REVIEW FOR THE INCISE COPING FOUND NO MANUFACTURING DEVIATIONS WHICH WOULD RESULT IN OR CONTRIBUTE TO THIS COMPLAINT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    ZIRCONIA COPING FRACTURE IN TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33448 3I INCISE ZR COPING SHADE 1 ZIRCONIA COPING NSP BIOMET 3I 144379

    Patients

    Seq Age Sex Outcome Treatment
    1