BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO IMPLANT 4MM WITH ABUTMENT 6 MM

    MDR report key: 1981173 · Received January 26, 2011

    Report

    Report Number
    3007367732-2011-00001
    Event Type
    Other
    Date Received
    January 26, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 24, 2011
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    LXB
    PMA / PMN Number
    K090996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SKIN OVERGROWTH IS A POSSIBLE EVENT DURING THIS PROCEDURE.

    Description of Event or Problem · 1

    PATIENT HAD SURGERY ON (B)(6) 2010. ON THE FOLLOW UP AFTER THREE MONTHS POST-OPERATIVELY, SKIN HAD GROWN OVER THE ABUTMENT. PATIENT IS SCHEDULED FOR A REVISION PROCEDURE IN OFFICE ON (B)(6) 2011. SURGEON WILL ALSO REPLACE 6 MM ABUTMENT WITH 9 MM ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PONTO IMPLANT 4MM WITH ABUTMENT 6 MM LXB - HEARING AID, BONE CONDUCTION LXB OTICON MEDICAL AB M50358 092012

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention