BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO IMPLANT WITH ABUTMENT

    MDR report key: 3894244 · Received June 18, 2014

    Report

    Report Number
    3007367732-2014-00028
    Event Type
    Other
    Date Received
    June 18, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 13, 2014
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    MAH
    PMA / PMN Number
    K121228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 MANUFACTURING OR COMPONENT FAILURE.

    Description of Event or Problem · 1

    PATIENTS IMPLANT BECAME LOOSE AFTER PLAYING BALL AT SCHOOL. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358386 PONTO IMPLANT WITH ABUTMENT BONE ANCHORED HEARING IMPLANT MAH OTICON MEDICAL AB M51140 113838

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention