BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3I INCISE ZR 6 UNIT FRAMEWORK SHADE 0

    MDR report key: 4593226 · Received March 12, 2015

    Report

    Report Number
    0001038806-2015-00431
    Event Type
    Malfunction
    Date Received
    March 12, 2015
    Report Date
    February 10, 2015
    Manufacturer
    BIOMET 3I
    Product Code
    ELZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FRACTURE OF THE 3I INCISE ZR 6 UNIT FRAMEWORK SHADE 0 COULD NOT BE VERIFIED, PRODUCT WASN'T RETURNED. THERE WERE NO MANUFACTURING DEVIATIONS IDENTIFIED WHICH WOULD CAUSE OR CONTRIBUTE TO THE REPORTED COMPLAINT. THE DHR WAS REVIEWED, THERE WERE NO MANUFACTURING DEVIATIONS IDENTIFIED WHICH WOULD RESULT IN OR CONTRIBUTE TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIRCONIA COPING BRIDGE HAS FRACTURED AFTER IT WAS PLACED IN THE PATIENTS MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171942 3I INCISE ZR 6 UNIT FRAMEWORK SHADE 0 ZIRCONIA COPING ELZ BIOMET 3I 143222

    Patients

    Seq Age Sex Outcome Treatment
    1