BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO IMPLANT WITH ABUTMENT

    MDR report key: 3941111 · Received July 7, 2014

    Report

    Report Number
    3007367732-2014-00030
    Event Type
    Other
    Date Received
    July 7, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 30, 2014
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    MAH
    PMA / PMN Number
    K121228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    PT SEEN FOR WOUND INFECTION ONE MONTH POSTOPERATIVE AND TREATED WITH ANTIBIOTICS FOR ONE MONTH. PT RETURNED FOR 3 MONTH F/U WHERE IT WAS OBSERVED THAT IMPLANT WAS LOOSE AND SITE WAS INFECTED AND TENDER. THE IMPLANT WAS LOOSE AND EXTRUDED. PT TO BE REIMPLANTED IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394676 PONTO IMPLANT WITH ABUTMENT BONE ANCHORED HEARING IMPLANT MAH OTICON MEDICAL AB M51138 131819

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention