BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO IMPLANT WITH ABUTMENT

    MDR report key: 3190412 · Received June 13, 2013

    Report

    Report Number
    3007367732-2013-00014
    Event Type
    Other
    Date Received
    June 13, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 13, 2013
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    LXB
    PMA / PMN Number
    K121228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT IMPLANTED ON (B)(6) 2013 AND IMPLANT CAME OUT ONE WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269839 PONTO IMPLANT WITH ABUTMENT BONE ANCHORED HEARING IMPLANT LXB OTICON MEDICAL AB M51137 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention