BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO IMPLANT WITH ABUTMENT

    MDR report key: 2860298 · Received November 29, 2012

    Report

    Report Number
    3007367732-2012-00025
    Event Type
    Other
    Date Received
    November 29, 2012
    Date of Event
    October 10, 2012
    Report Date
    November 29, 2012
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    LXB
    PMA / PMN Number
    K082108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO SWAP OUT PERCUTANEOUS ABUTMENT. DURING THE PROCEDURE, THE IMPLANT WAS INADVERTENTLY TAKEN OUT OF THE SKULL. PT IS SCHEDULED FOR REIMPLANTATION ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PONTO IMPLANT WITH ABUTMENT BONE ANCHORED HEARING IMPLATN LXB OTICON MEDICAL AB M50358 111714

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention