BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DO NOT USE-3I INCISE ZR COPING SHADE 2

    MDR report key: 6759541 · Received August 2, 2017

    Report

    Report Number
    0001038806-2017-00473
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Report Date
    September 28, 2017
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE INCISE ZR COPING WAS RETURNED FOR INSPECTION CEMENTED TO A THREE UNIT BRIDGE. VISUAL INSPECTION REVEALED THAT THE COPING IS FRACTURED AT THE BOTTOM OF THE FEATURE. THE REMAINING SIDE OF THE COPING COULD NOT BE VIEWED IN THIS CONDITION. RETURNED DEVICES WERE EXAMINED VISUALLY BY THE NAKED EYE AND THROUGH MAGNIFICATION. THE COMPLAINT WAS CONFIRMED. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT IDENTIFY ANY NON-CONFORMANCES. THERE WERE NO MANUFACTURING DEVIATIONS IDENTIFIED WHICH WOULD CAUSE OR CONTRIBUTE TO THIS COMPLAINT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED. AS THE PRODUCT HAS BEEN OBSOLETED, NO ADDITIONAL ACTIONS ARE REQUIRED. DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO¿ TO ¿YES¿.

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE - ELZ (PRODUCT IS OBSOLETE).

    Description of Event or Problem · 1

    THE DOCTOR REPORTED ZIRCONIA COOPING FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540471 DO NOT USE-3I INCISE ZR COPING SHADE 2 COPING NHA BIOMET 3I 141217

    Patients

    Seq Age Sex Outcome Treatment
    1