BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO IMPLANT WITH ABUTMENT

    MDR report key: 3941098 · Received July 7, 2014

    Report

    Report Number
    3007367732-2014-00032
    Event Type
    Other
    Date Received
    July 7, 2014
    Date of Event
    April 27, 2014
    Report Date
    July 1, 2014
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    MAH
    PMA / PMN Number
    K121228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT LOSS IS KNOWN TO OCCUR, CONSIDERED IN THE RMF AND COMMUNICATED IN THE IFU. THERE ARE NO INDICATIONS THAT THE OCCURRED IS A RESULT OF MFG OR COMPONENT FAILURE.

    Description of Event or Problem · 1

    IMPLANT LOSS 9 WEEKS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394674 PONTO IMPLANT WITH ABUTMENT BONE ANCHORED HEARING IMPLANT MAH OTICON MEDICAL AB M51137 113735

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention