BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO IMPLANT 4MM WITH ABUTMENT 6MM

    MDR report key: 2163575 · Received March 18, 2011

    Report

    Report Number
    3007367732-2011-00004
    Event Type
    Other
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 24, 2011
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    LXB
    PMA / PMN Number
    K090996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT HAS NOT BEEN RETURNED TO OTICON MEDICAL AT THE TIME OF THIS REPORT. THERE ARE NO INDICATIONS THAT THE OCCURRED IS A RESULT OF MANUFACTURING OR COMPONENT FAILURE. THE EVENT IS KNOWN TO OCCUR, BASED ON KNOWN FACTS FOR TITANIUM IMPLANTS INTENDED FOR OSSEOINTEGRATION.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON (B)(6) 2010, WITHOUT COMPLICATION. SEEN FOR FOLLOW-UP ON (B)(6) 2011, WITHOUT ANY OBSERVED COMPLICATION AND NORMAL WOUND HEALING. ON (B)(6) 2011, PATIENT NOTED A LOOSE IMPLANT, WAS SEEN BY A PHYSICIAN WHO OBSERVED GRANULATION TISSUE AND LOOSE IMPLANT. WAS SEEN AGAIN ON (B)(6) 2011, WHEN PHYSICIAN ATTEMPTED TIGHTENING OF THE IMPLANT AND THEN NOTED THAT THE IMPLANT DID NOT INTEGRATE IN THE BONE. IMPLANT WAS REMOVED WITHOUT INCIDENT. PATIENT IS USING ANTIBIOTICS AND WILL BE SEEN FOR FOLLOW-UP (B)(6) 2011 TO CONSIDER RE-IMPLANTATION AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PONTO IMPLANT 4MM WITH ABUTMENT 6MM LXB - HEARING AID, BONE CONDUCTION LXB OTICON MEDICAL AB M50358 102319

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention