BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3I INCISE ZR 4 UNIT FRAMEWORK SHADE 5

    MDR report key: 5402363 · Received February 1, 2016

    Report

    Report Number
    0001038806-2016-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Report Date
    January 7, 2016
    Manufacturer
    BIOMET 3I
    Product Code
    NSP
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DID NOT RETURN; THEREFORE NO EVALUATION COULD BE PERFORMED AND COMPLAINT COULD NOT BE CONFIRMED. THE LOT NUMBER FOR THE ZIRCONIA COPING WAS NOT PROVIDED AND THEREFORE A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. A REVIEW OF COMPLAINT TRENDING DID NOT PROVIDE INDICATION OF A MANUFACTURING DEVIATION. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE IS ELZ. (CODE WAS NOT AVAILABLE IN DROP DOWN LIST) DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE LAB TECH INDICATED THAT THE ZIRCONIA COPING (CBZR0405) FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61492 3I INCISE ZR 4 UNIT FRAMEWORK SHADE 5 ZIRCONIA COPING NSP BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1