BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO IMPLANT WITH ABUTMENT

    MDR report key: 3031895 · Received March 22, 2013

    Report

    Report Number
    3007367732-2013-00007
    Event Type
    Other
    Date Received
    March 22, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 21, 2013
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    MAH
    PMA / PMN Number
    K121228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAS CHRONIC EAR INFECTIONS. WILL BE EXPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119902 PONTO IMPLANT WITH ABUTMENT BONE ANCHORED HEARING IMPLANT MAH OTICON MEDICAL AB M50358 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention