BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO IMPLANT 4MM

    MDR report key: 2912937 · Received December 21, 2012

    Report

    Report Number
    3007367732-2012-00029
    Event Type
    Other
    Date Received
    December 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    LXB
    PMA / PMN Number
    K082108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IMPLANT FELL OUT. PT HAD REIMPLANT SURGERY ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PONTO IMPLANT 4MM BONE ANCHORED HEARING IMPLANT LXB OTICON MEDICAL AB M50220 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention