BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO IMPLANT WITH ABUTMENT

    MDR report key: 2930931 · Received January 10, 2013

    Report

    Report Number
    3007367732-2013-00001
    Event Type
    Other
    Date Received
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    LXB
    PMA / PMN Number
    K082108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RIGHT SIDED IMPLANT - DUE TO CHRONIC INFECTIONS AT THE IMPLANT/ABUTMENT SITE, THE ABUTMENT WAS REMOVED AND PT SCHEDULED FOR EXPLANT OF IMPLANT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14062 PONTO IMPLANT WITH ABUTMENT BONE ANCHORED HEARING IMPLANT LXB OTICON MEDICAL AB M50784 111717

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention