BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROXYLAPATITE AND FLEX H/A/

    MDR report key: 5240054 · Received November 17, 2015

    Report

    Report Number
    MW5057969
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    November 12, 2015
    Report Date
    November 17, 2015
    Manufacturer
    MEDTRONIC XOMED
    Product Code
    FZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING LEFT MIDDLE EAR EXPLORATION AND TORP REVISION, PERFORMED DUE TO WORSENING HEARING LOSS, THE EAR PROSTHESIS WAS FOUND DISPLACED AND DEFECTIVE. PHOTOGRAPHIC DOCUMENTATION WAS TAKEN OF THE DEFECT, AND IT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761006 HYDROXYLAPATITE AND FLEX H/A/ EAR PROSTHESIS FZD MEDTRONIC XOMED 0590 0208855737

    Patients

    Seq Age Sex Outcome Treatment
    1 10/18/1